Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (NCT NCT03616912)
NCT ID: NCT03616912
Last Updated: 2023-01-30
Results Overview
SRI-4 response defined as 1)greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
830 participants
Primary outcome timeframe
Week 52
Results posted on
2023-01-30
Participant Flow
One investigational site with seven participants was excluded from analysis due to confirmed misconduct.
Participant milestones
| Measure |
Placebo
Participants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
|
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
Placebo (MEE)
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
2 mg Baricitinib (MEE)
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
|
4 mg Baricitinib (MEE)
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
257
|
258
|
254
|
21
|
20
|
20
|
|
Overall Study
Received at Least One Dose of Study Drug
|
257
|
256
|
254
|
21
|
20
|
20
|
|
Overall Study
Excluded Due to Site Misconduct
|
4
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
204
|
211
|
208
|
5
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
53
|
47
|
46
|
16
|
15
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Participants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
|
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
Placebo (MEE)
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
2 mg Baricitinib (MEE)
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
|
4 mg Baricitinib (MEE)
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
17
|
21
|
9
|
0
|
0
|
0
|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
13
|
6
|
8
|
4
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
3
|
0
|
0
|
0
|
|
Overall Study
Due to Epidemic/Pandemic
|
4
|
2
|
5
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
15
|
2
|
0
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
10
|
9
|
11
|
|
Overall Study
Protocol Deviation
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
4
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Randomized But Never Treated
|
0
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Placebo
n=253 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
2 mg Baricitinib
n=255 Participants
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
|
4 mg Baricitinib
n=252 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
Placebo Maximum Extended Enrollment (MEE)
n=21 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
2 mg Baricitinib MEE
n=20 Participants
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
|
4 mg Baricitinib MEE
n=20 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
Total
n=821 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.00 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
42.90 years
STANDARD_DEVIATION 12.44 • n=7 Participants
|
41.50 years
STANDARD_DEVIATION 12.88 • n=5 Participants
|
32.90 years
STANDARD_DEVIATION 10.83 • n=4 Participants
|
37.70 years
STANDARD_DEVIATION 11.38 • n=21 Participants
|
34.60 years
STANDARD_DEVIATION 8.31 • n=8 Participants
|
41.60 years
STANDARD_DEVIATION 12.43 • n=8 Participants
|
|
Sex: Female, Male
Female
|
237 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
771 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
115 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
207 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
678 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
167 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
89 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
168 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
517 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Region of Enrollment
Austria
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
Brazil
|
38 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
83 Participants
n=8 Participants
|
|
Region of Enrollment
China
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
116 Participants
n=8 Participants
|
|
Region of Enrollment
Croatia
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Region of Enrollment
Czechia
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
38 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
Region of Enrollment
Greece
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Region of Enrollment
Hungary
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
|
Region of Enrollment
Israel
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Region of Enrollment
Mexico
|
36 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
136 Participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
Russia
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
71 Participants
n=8 Participants
|
|
Region of Enrollment
Switzerland
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Region of Enrollment
Taiwan
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
146 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (Modified intent to treat (mITT population). Missing data was imputed using the hybrid imputation method \[nonresponder imputation (NRI) + multiple imputation (MI)\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
SRI-4 response defined as 1)greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).
Outcome measures
| Measure |
Placebo
n=253 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=252 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)
|
45.9 percentage of participants
|
56.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). Missing data was imputed using the hybrid imputation method \[nonresponder imputation (NRI) + multiple imputation (MI)\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
SRI-4 response defined as 1)greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).
Outcome measures
| Measure |
Placebo
n=253 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=255 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib
|
45.9 percentage of participants
|
49.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). Missing data was imputed using the hybrid imputation method \[nonresponder imputation (NRI) + multiple imputation (MI)\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K \<=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), \<=1; (4) current prednisolone (or equivalent) dose \<=7.5 mg daily.
Outcome measures
| Measure |
Placebo
n=253 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=255 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=252 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
|
26.2 percentage of participants
|
25.7 percentage of participants
|
29.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Time to first severe flare was analyzed using a Cox proportional hazards model with treatment group, baseline disease activity (Systemic Lupus Erythematosus Disease Activity Index 2000 \[SLEDAI-2K \] \<10; SLEDAI-2K ≥10), baseline corticosteroid dose (\<10 mg/day; ≥10 mg/day prednisone or equivalent), and region fitted as explanatory variables. Participants who did not have severe flare during the flare exposure time period were censored at the end of the flare exposure time.
Outcome measures
| Measure |
Placebo
n=253 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=255 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=252 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Time to First Severe Flare
|
NA weeks
Data not available (NA) as \< 50% of participants experienced first flare, median was not reached and 95% confidence interval could not be calculated.
|
NA weeks
Data not available (NA) as \< 50% of participants experienced first flare, median was not reached and 95% confidence interval could not be calculated.
|
NA weeks
Data not available (NA) as \< 50% of participants experienced first flare, median was not reached and 95% confidence interval could not be calculated.
|
SECONDARY outcome
Timeframe: Baseline, Week 40 through Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and received \>7.5 mg prednisone at baseline. Missing data was imputed using the hybrid imputation method \[NRI + modified last observation carried forward\]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
For the analysis of steroid use, steroid dosages were converted to a prednisone equivalent in mg. A responder was defined as having a prednisone reduction by \>=25% from Baseline to \<=7.5 mg/day during Weeks 40 through 52.
Outcome measures
| Measure |
Placebo
n=117 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=106 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=106 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Percentage of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Participants Receiving Greater Than 7.5 mg/Day at Baseline
|
30.8 percentage of participants
|
29.2 percentage of participants
|
34.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. Missing data was imputed using the hybrid imputation method (NRI + MMRM). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Participants assessed their worst pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The average worst daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \<10; \>=10), baseline corticosteroid dose (\<10 mg/day; \>= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=173 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=173 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=182 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
|
-1.62 score on a scale
Standard Error 0.15
|
-1.73 score on a scale
Standard Error 0.15
|
-1.71 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time-point. Missing data was imputed using the hybrid imputation method (NRI + MMRM). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
FACIT-Fatigue score calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \<10; \>=10), baseline corticosteroid dose (\<10 mg/day; \>= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=188 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=201 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=204 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score
|
7.44 score on a scale
Standard Error 0.62
|
7.46 score on a scale
Standard Error 0.60
|
7.08 score on a scale
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline CLASI score of \>= 10. Missing data was imputed using NRI method. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=46 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=43 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score
|
49.0 percentage of participants
|
54.3 percentage of participants
|
55.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at specified time point. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K \<10; \>=10), baseline corticosteroid dose (\<10 mg/day; \>=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=183 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=198 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=195 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Tender Joints Count
|
-7.50 tender joint count
Standard Error 0.312
|
-7.26 tender joint count
Standard Error 0.305
|
-7.94 tender joint count
Standard Error 0.307
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K \<10; \>=10), baseline corticosteroid dose (\<10 mg/day; \>=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
Outcome measures
| Measure |
Placebo
n=183 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=198 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=195 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Swollen Joint Count
|
-5.37 swollen joint count
Standard Error 0.201
|
-5.67 swollen joint count
Standard Error 0.196
|
-5.81 swollen joint count
Standard Error 0.198
|
SECONDARY outcome
Timeframe: Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) was evaluated using population PK approach.
Outcome measures
| Measure |
Placebo
n=248 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=220 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)
|
256 hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 52
|
502 hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 52
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) was evaluated using population PK approach.
Outcome measures
| Measure |
Placebo
n=248 Participants
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
n=220 Participants
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|
|
Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)
|
26.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
53.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
—
|
Adverse Events
Placebo
Serious events: 19 serious events
Other events: 129 other events
Deaths: 1 deaths
2 mg Baricitinib
Serious events: 27 serious events
Other events: 144 other events
Deaths: 1 deaths
4 mg Baricitinib
Serious events: 31 serious events
Other events: 144 other events
Deaths: 0 deaths
Placebo Maximum Extended Enrollment (MEE)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
2 mg Baricitinib (MEE)
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
4 mg Baricitinib (MEE)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=253 participants at risk
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
2 mg Baricitinib
n=255 participants at risk
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
|
4 mg Baricitinib
n=252 participants at risk
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
Placebo Maximum Extended Enrollment (MEE)
n=21 participants at risk
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks
|
2 mg Baricitinib (MEE)
n=20 participants at risk
Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
|
4 mg Baricitinib (MEE)
n=20 participants at risk
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Death
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Immune system disorders
Drug hypersensitivity
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Infection
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
4/255 • Number of events 5 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
2/252 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral myocarditis
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral pericarditis
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
2/252 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Device use issue
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
4/252 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.42%
1/237 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/238 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage 0
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.42%
1/237 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/238 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.42%
1/237 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/238 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.42%
1/237 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Major depression
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.78%
2/255 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/238 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.42%
1/237 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/238 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.42%
1/237 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.42%
1/238 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.42%
1/237 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/238 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Vasculitis
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=253 participants at risk
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
|
2 mg Baricitinib
n=255 participants at risk
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
|
4 mg Baricitinib
n=252 participants at risk
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
Placebo Maximum Extended Enrollment (MEE)
n=21 participants at risk
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks
|
2 mg Baricitinib (MEE)
n=20 participants at risk
Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
|
4 mg Baricitinib (MEE)
n=20 participants at risk
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
4/253 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
4/255 • Number of events 6 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
13/252 • Number of events 16 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
3/21 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
4/255 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.0%
10/253 • Number of events 13 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
11/255 • Number of events 14 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
9/252 • Number of events 10 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
3/21 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.78%
2/255 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
3/252 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
10/253 • Number of events 12 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
10/255 • Number of events 12 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.0%
10/252 • Number of events 12 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
4/255 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
2/252 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.78%
2/255 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
5/253 • Number of events 5 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
11/255 • Number of events 13 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
12/252 • Number of events 14 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
5/255 • Number of events 5 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
3/252 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
4/252 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
3/255 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/252 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
3.6%
9/253 • Number of events 9 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.3%
16/255 • Number of events 16 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.2%
13/252 • Number of events 13 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gingivitis
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.40%
1/252 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
3.2%
8/253 • Number of events 8 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
9/255 • Number of events 9 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.3%
16/252 • Number of events 18 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
17/253 • Number of events 24 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.5%
19/255 • Number of events 21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
18/252 • Number of events 24 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
17/253 • Number of events 19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
21/255 • Number of events 30 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.5%
19/252 • Number of events 27 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
23.8%
5/21 • Number of events 11 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
45.0%
9/20 • Number of events 17 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
35.0%
7/20 • Number of events 8 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
9.9%
25/253 • Number of events 38 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
32/255 • Number of events 41 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.7%
37/252 • Number of events 47 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.0%
3/20 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/238 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/237 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
2.8%
7/253 • Number of events 7 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.4%
6/255 • Number of events 8 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
2/252 • Number of events 5 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.2%
3/253 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
8/255 • Number of events 9 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
14/252 • Number of events 20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/255 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
2/252 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
2.8%
7/253 • Number of events 9 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
5/255 • Number of events 5 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
3/252 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.40%
1/253 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.78%
2/255 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.4%
6/252 • Number of events 6 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
3/21 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
4/20 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.0%
3/20 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.6%
4/253 • Number of events 5 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.5%
9/255 • Number of events 9 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
3/252 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
23.8%
5/21 • Number of events 5 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.40%
1/253 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.78%
2/255 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
2/252 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.0%
3/20 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
4/20 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
1.6%
4/253 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
5/252 • Number of events 6 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.0%
3/20 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
9.9%
25/253 • Number of events 26 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.3%
16/255 • Number of events 19 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.9%
20/252 • Number of events 23 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
1/21 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/253 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.39%
1/255 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
2/252 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
3.2%
8/253 • Number of events 8 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
4/255 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
5/252 • Number of events 6 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/16 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/15 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
—
0/0 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
7/253 • Number of events 7 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
5/255 • Number of events 5 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
7/252 • Number of events 7 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.2%
3/253 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
3/255 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
4/252 • Number of events 4 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
2/21 • Number of events 3 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
4.0%
10/253 • Number of events 10 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.7%
17/255 • Number of events 18 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.7%
17/252 • Number of events 18 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline through Follow-up (Up to 56 Weeks)
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60