Trial Outcomes & Findings for A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease (NCT NCT02891226)
NCT ID: NCT02891226
Last Updated: 2022-08-30
Results Overview
Endoscopic response defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD calculated as sum of 4 variables for 5 bowel segments: (ileum;right,transverse,and left colon;and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; \>2 cm = score 3); extent of ulcerated surface (none = 0; \<10% = 1;10-30% = 2;\>30% = 3);extent of affected surface (none = 0; \<50% = 1;50-75% = 2;\>75% =3); and presence and type of narrowings (none=0; single, can be passed=1; multiple,can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
191 participants
Primary outcome timeframe
Week 12
Results posted on
2022-08-30
Participant Flow
Participant milestones
| Measure |
Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)
Participants received placebo administered intravenously (IV) Q4W.
|
Period 1: 200 Milligram (mg) Mirikizumab IV Q4W
Participants received 200 mg mirikizumab administered IV Q4W.
|
Period 1: 600 mg Mirikizumab IV Q4W
Participants received 600 mg mirikizumab administered IV Q4W.
|
Period 1: 1000 mg Mirikizumab IV Q4W
Participants received 1000 mg mirikizumab administered IV Q4W.
|
Period 2: 200 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
Participants received 200 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
Participants received 600 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
Participants received 1000 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)
Participants received 300 mg mirikizumab administered SC Q4W. Participants improved on any mirikizumab dose in Period 1.
|
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)
Participants who did not improve in Period 1 on mirikizumab (any dose) received 1000 mg mirikizumab administered IV Q4W.
|
Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)
Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.
|
Period 3: 300 mg Mirikizumab SC Q4W
Participants received 300 mg mirikizumab administered SC Q4W.
|
Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2
Participants did not receive drug during the follow-up period. Group includes participants who received 200 mg mirikizumab IV Q4W during period 2.
|
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Improvers)
Participants did not receive drug during the follow-up period. Group includes participants who received 1000 mg mirikizumab IV Q4W during period 2 after improving on the same dose in Period 1.
|
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)
Participants did not receive drug during the follow-up period. Group includes participants who did not improve in period 1, and received 1000 mg mirikizumab IV Q4W during period 2.
|
Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)
Participants did not receive drug during the follow-up period. Group includes participants who received placebo in period 1 and 1000 mg mirikizumab administered IV Q4W.
|
Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
Participants did not receive drug during the follow-up period. Group includes participants who received 300 mg mirikizumab administered SC Q4W during period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1 (Weeks 0 to 12)
STARTED
|
64
|
31
|
32
|
64
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 to 12)
Received at Least 1 Dose of Study Drug
|
64
|
31
|
32
|
64
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 to 12)
COMPLETED
|
59
|
29
|
28
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 to 12)
NOT COMPLETED
|
5
|
2
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
STARTED
|
0
|
0
|
0
|
0
|
9
|
9
|
23
|
46
|
30
|
59
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
COMPLETED
|
0
|
0
|
0
|
0
|
8
|
8
|
20
|
41
|
24
|
42
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
5
|
6
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
137
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
137
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
3
|
|
Follow-up Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
2
|
|
Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)
Participants received placebo administered intravenously (IV) Q4W.
|
Period 1: 200 Milligram (mg) Mirikizumab IV Q4W
Participants received 200 mg mirikizumab administered IV Q4W.
|
Period 1: 600 mg Mirikizumab IV Q4W
Participants received 600 mg mirikizumab administered IV Q4W.
|
Period 1: 1000 mg Mirikizumab IV Q4W
Participants received 1000 mg mirikizumab administered IV Q4W.
|
Period 2: 200 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
Participants received 200 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
Participants received 600 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
Participants received 1000 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)
Participants received 300 mg mirikizumab administered SC Q4W. Participants improved on any mirikizumab dose in Period 1.
|
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)
Participants who did not improve in Period 1 on mirikizumab (any dose) received 1000 mg mirikizumab administered IV Q4W.
|
Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)
Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.
|
Period 3: 300 mg Mirikizumab SC Q4W
Participants received 300 mg mirikizumab administered SC Q4W.
|
Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2
Participants did not receive drug during the follow-up period. Group includes participants who received 200 mg mirikizumab IV Q4W during period 2.
|
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Improvers)
Participants did not receive drug during the follow-up period. Group includes participants who received 1000 mg mirikizumab IV Q4W during period 2 after improving on the same dose in Period 1.
|
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)
Participants did not receive drug during the follow-up period. Group includes participants who did not improve in period 1, and received 1000 mg mirikizumab IV Q4W during period 2.
|
Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)
Participants did not receive drug during the follow-up period. Group includes participants who received placebo in period 1 and 1000 mg mirikizumab administered IV Q4W.
|
Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
Participants did not receive drug during the follow-up period. Group includes participants who received 300 mg mirikizumab administered SC Q4W during period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1 (Weeks 0 to 12)
Adverse Event
|
4
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 to 12)
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 to 12)
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 to 12)
Enrollment Failure
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 to 12)
Sponsor Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 (Weeks 0 to 12)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
PI decision due to Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
PI and Sponsor Decision due to Subject Safety
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
PI Decision due to Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
Endoscopic Procedure was not Evaluated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
Lack of Efficacy and Withdrew from Study
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (Weeks 12 to 52)
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
Roll over to AMAX
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
108
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
Decided to not Participate in Extension Period (Week 104-208)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
PI Decision as Subject Not Responding to Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (Weeks 52 to 208)
Non-Compliance With Study Visit Schedule
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Placebo IV Q4W
n=64 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
n=31 Participants
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
n=32 Participants
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
n=64 Participants
Participants received 1000 mg mirikizumab administered IV Q4W.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.00 years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
38.10 years
STANDARD_DEVIATION 11.80 • n=7 Participants
|
40.40 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
37.70 years
STANDARD_DEVIATION 13.11 • n=4 Participants
|
38.70 years
STANDARD_DEVIATION 12.70 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
159 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
Australia
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
Russia
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants.
Endoscopic response defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD calculated as sum of 4 variables for 5 bowel segments: (ileum;right,transverse,and left colon;and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; \>2 cm = score 3); extent of ulcerated surface (none = 0; \<10% = 1;10-30% = 2;\>30% = 3);extent of affected surface (none = 0; \<50% = 1;50-75% = 2;\>75% =3); and presence and type of narrowings (none=0; single, can be passed=1; multiple,can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo IV Q4W
n=64 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
n=31 Participants
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
n=32 Participants
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
n=64 Participants
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Endoscopic Response at Week 12
|
10.9 percentage of participants
Interval 4.5 to 17.4
|
25.8 percentage of participants
Interval 12.9 to 38.7
|
37.5 percentage of participants
Interval 23.4 to 51.6
|
43.8 percentage of participants
Interval 33.6 to 53.9
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants.
Endoscopic remission defined as SES-CD of \<4 ileal-colonic or \<2 for isolated ileal disease, and no subscore \>1 at week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: (ileum; right, transverse, and left colon; and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; greater than (\>) 2 cm = score 3); extent of ulcerated surface (none = 0; less than (\<) 10% = 1; 10-30% = 2; \>30% = 3); extent of affected surface (none = 0; \<50% = 1; 50-75% = 2; \>75% = 3); and presence and type of narrowings (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Placebo IV Q4W
n=64 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
n=31 Participants
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
n=32 Participants
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
n=64 Participants
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Endoscopic Remission at Week 12
|
1.6 percentage of participants
Interval 0.0 to 4.1
|
6.5 percentage of participants
Interval 0.0 to 13.7
|
15.6 percentage of participants
Interval 5.1 to 26.2
|
20.3 percentage of participants
Interval 12.0 to 28.6
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants.
PRO remission is defined as stool frequency (SF) ≤2.5 and abdominal pain (AP) ≤1 and no worse than baseline at week 12. SF captures the number of liquid or very soft stools. AP score is classified as 0=none, 1=mild, 2=moderate, 3=severe.
Outcome measures
| Measure |
Placebo IV Q4W
n=64 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
n=31 Participants
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
n=32 Participants
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
n=64 Participants
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12
|
6.3 percentage of participants
Interval 1.3 to 11.2
|
12.9 percentage of participants
Interval 3.0 to 22.8
|
28.1 percentage of participants
Interval 15.1 to 41.2
|
21.9 percentage of participants
Interval 13.4 to 30.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who had a baseline and at least one post-baseline PGRS value.
The PGRS is a 1-item patient-rated questionnaire designed to assess the participant's rating of their disease symptom severity over the past 24 hours. Responses are graded on a 6-point scale in which a score of 1 indicates the subject has no symptoms (that is, "none") and a score of 6 indicates that the participant's symptom are "very severe." Least Squares Mean (LS Mean) was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Outcome measures
| Measure |
Placebo IV Q4W
n=58 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
n=26 Participants
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
n=29 Participants
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
n=56 Participants
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12
|
-0.44 score on a scale
Standard Error 0.132
|
-1.08 score on a scale
Standard Error 0.194
|
-1.27 score on a scale
Standard Error 0.189
|
-0.98 score on a scale
Standard Error 0.134
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who had a baseline and at least one post-baseline PGRC value.
The PGRC scale is a patient-rated instrument designed to assess the participant's rating of change in their symptom(s). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the participant's symptom is "very much better," a score of 4 indicates that the participant's symptom has experienced "no change," and a score of 7 indicates that the participant's symptom is "very much worse."
Outcome measures
| Measure |
Placebo IV Q4W
n=56 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
n=29 Participants
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
n=27 Participants
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
n=57 Participants
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12
|
3.6 score on a scale
Standard Deviation 1.11
|
2.8 score on a scale
Standard Deviation 1.26
|
2.6 score on a scale
Standard Deviation 0.97
|
2.5 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who had a baseline and at least one post-baseline IBDQ value.
The IBDQ is a 32-item self-administered questionnaire. The IBDQ has 4 dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Outcome measures
| Measure |
Placebo IV Q4W
n=56 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
n=29 Participants
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
n=28 Participants
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
n=57 Participants
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
|
17.11 score on a scale
Standard Error 3.725
|
41.16 score on a scale
Standard Error 5.311
|
46.57 score on a scale
Standard Error 5.244
|
42.35 score on a scale
Standard Error 3.770
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who had a baseline and at least one post-baseline FACIT-F value.
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0-4 associated with a range over "Not at all" to "Very much" for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Outcome measures
| Measure |
Placebo IV Q4W
n=56 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
n=29 Participants
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
n=28 Participants
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
n=57 Participants
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
|
2.90 score on a scale
Standard Error 1.209
|
10.81 score on a scale
Standard Error 1.728
|
9.09 score on a scale
Standard Error 1.721
|
9.62 score on a scale
Standard Error 1.223
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who had a baseline and at least one post-baseline PCS and MCS value.
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains:physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Outcome measures
| Measure |
Placebo IV Q4W
n=56 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
n=29 Participants
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
n=28 Participants
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
n=57 Participants
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12
MCS
|
2.34 score on a scale
Standard Error 1.133
|
7.47 score on a scale
Standard Error 1.602
|
6.52 score on a scale
Standard Error 1.592
|
6.05 score on a scale
Standard Error 1.152
|
|
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12
PCS
|
3.11 score on a scale
Standard Error 0.774
|
4.70 score on a scale
Standard Error 1.096
|
8.01 score on a scale
Standard Error 1.108
|
6.70 score on a scale
Standard Error 0.787
|
SECONDARY outcome
Timeframe: Week 0, 4, 8: Predose, end of infusion; Week 2; 4; 6; 8, 11-12; 12-13; 16; 20; 24; 28; 36; 44; 52; 60; 68; 76; 84; 92; 104; 108; 112; 120; 128; 136; 144; 156; 164; 172; 180; 188; 196 and 208 weeks post infusionPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Population mean (between-subject coefficient variance \[CV %\]) apparent clearance. Clearance is estimated based on concentration data collected in the time frame of 0-208 weeks.
Outcome measures
| Measure |
Placebo IV Q4W
n=186 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab
|
0.0225 Liters per Hour (L/h)
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 4, 8: Predose, end of infusion; Week 2; 4; 6; 8, 11-12; 12-13; 16; 20; 24; 28; 36; 44; 52; 60; 68; 76; 84; 92; 104; 108; 112; 120; 128; 136; 144; 156; 164; 172; 180; 188; 196 and 208 weeks post infusionPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Population mean (between-subject coefficient variance \[CV %\]) apparent volume of distribution. Volume of distribution is estimated based on concentration data collected in the time frame of 0-208 weeks.
Outcome measures
| Measure |
Placebo IV Q4W
n=186 Participants
Participants received placebo administered IV Q4W.
|
200 mg Mirikizumab IV Q4W
Participants received 200 mg mirikizumab administered IV Q4W.
|
600 mg Mirikizumab IV Q4W
Participants received 600 mg mirikizumab administered IV Q4W.
|
1000 mg Mirikizumab IV Q4W
Participants received 1000 mg mirikizumab administered IV Q4W.
|
|---|---|---|---|---|
|
Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab
|
5.05 Liters (L)
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
Adverse Events
Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Period 1: 200 Milligram (mg) Mirikizumab IV Q4W
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Period 1: 600 mg Mirikizumab IV Q4W
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Period 1: 1000 mg Mirikizumab IV Q4W
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Period 2: 200 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)
Serious events: 9 serious events
Other events: 30 other events
Deaths: 0 deaths
Period 3: 300 mg Mirikizumab SC Q4W
Serious events: 15 serious events
Other events: 89 other events
Deaths: 0 deaths
Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Improvers)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)
n=64 participants at risk
Participants received placebo administered intravenously (IV) Q4W.
|
Period 1: 200 Milligram (mg) Mirikizumab IV Q4W
n=31 participants at risk
Participants received 200 mg mirikizumab administered IV Q4W.
|
Period 1: 600 mg Mirikizumab IV Q4W
n=32 participants at risk
Participants received 600 mg mirikizumab administered IV Q4W.
|
Period 1: 1000 mg Mirikizumab IV Q4W
n=64 participants at risk
Participants received 1000 mg mirikizumab administered IV Q4W.
|
Period 2: 200 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
n=9 participants at risk
Participants received 200 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
n=9 participants at risk
Participants received 600 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
n=23 participants at risk
Participants received 1000 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)
n=46 participants at risk
Participants received 300 mg mirikizumab administered SC Q4W. Participants improved on any mirikizumab dose in Period 1.
|
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)
n=30 participants at risk
Participants who did not improve in Period 1 on mirikizumab (any dose) received 1000 mg mirikizumab administered IV Q4W.
|
Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)
n=59 participants at risk
Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.
|
Period 3: 300 mg Mirikizumab SC Q4W
n=136 participants at risk
Participants received 300 mg mirikizumab administered SC Q4W.
|
Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2
n=1 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who received 200 mg mirikizumab IV Q4W during period 2.
|
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Improvers)
n=2 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who received 1000 mg mirikizumab IV Q4W during period 2 after improving on the same dose in Period 1.
|
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)
n=1 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who did not improve in period 1, and received 1000 mg mirikizumab IV Q4W during period 2.
|
Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)
n=1 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who received placebo in period 1 and 1000 mg mirikizumab administered IV Q4W.
|
Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
n=3 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who received 300 mg mirikizumab administered SC Q4W during period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Concussion
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Crohn's disease
|
4.7%
3/64 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
2/136 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Malaise
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
2/59 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Intestinal anastomosis complication
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Maternal exposure during pregnancy
|
0.00%
0/36 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Paternal exposure during pregnancy
|
0.00%
0/28 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/17 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/17 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
2/75 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood potassium decreased
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Back pain
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Rotator cuff syndrome
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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)
Gastrointestinal tract adenoma
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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%
0/36 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)
n=64 participants at risk
Participants received placebo administered intravenously (IV) Q4W.
|
Period 1: 200 Milligram (mg) Mirikizumab IV Q4W
n=31 participants at risk
Participants received 200 mg mirikizumab administered IV Q4W.
|
Period 1: 600 mg Mirikizumab IV Q4W
n=32 participants at risk
Participants received 600 mg mirikizumab administered IV Q4W.
|
Period 1: 1000 mg Mirikizumab IV Q4W
n=64 participants at risk
Participants received 1000 mg mirikizumab administered IV Q4W.
|
Period 2: 200 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
n=9 participants at risk
Participants received 200 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
n=9 participants at risk
Participants received 600 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)
n=23 participants at risk
Participants received 1000 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.
|
Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)
n=46 participants at risk
Participants received 300 mg mirikizumab administered SC Q4W. Participants improved on any mirikizumab dose in Period 1.
|
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)
n=30 participants at risk
Participants who did not improve in Period 1 on mirikizumab (any dose) received 1000 mg mirikizumab administered IV Q4W.
|
Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)
n=59 participants at risk
Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.
|
Period 3: 300 mg Mirikizumab SC Q4W
n=136 participants at risk
Participants received 300 mg mirikizumab administered SC Q4W.
|
Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2
n=1 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who received 200 mg mirikizumab IV Q4W during period 2.
|
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Improvers)
n=2 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who received 1000 mg mirikizumab IV Q4W during period 2 after improving on the same dose in Period 1.
|
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)
n=1 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who did not improve in period 1, and received 1000 mg mirikizumab IV Q4W during period 2.
|
Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)
n=1 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who received placebo in period 1 and 1000 mg mirikizumab administered IV Q4W.
|
Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
n=3 participants at risk
Participants did not receive drug during the follow-up period. Group includes participants who received 300 mg mirikizumab administered SC Q4W during period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Respiratory tract infection viral
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
2/136 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
3/59 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
5/136 • Number of events 8 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
2/30 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.5%
5/59 • Number of events 6 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
7/136 • Number of events 8 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.7%
2/23 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
3/59 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
8/136 • Number of events 10 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
2/136 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Crohn's disease
|
9.4%
6/64 • Number of events 7 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
8/136 • Number of events 10 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
100.0%
1/1 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
6/136 • Number of events 7 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/64 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
3/59 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
6/136 • Number of events 8 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
4.7%
3/64 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.8%
4/59 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
7/136 • Number of events 7 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Infusion site reaction
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 15 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.7%
4/46 • Number of events 64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 7 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
3/59 • Number of events 16 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
8/136 • Number of events 162 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
3/46 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.2%
18/136 • Number of events 114 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
2/30 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
6/136 • Number of events 6 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
2/136 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/28 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/17 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.1%
1/11 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/17 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/75 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Human anaplasmosis
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
5/136 • Number of events 5 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.7%
2/23 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.0%
6/46 • Number of events 7 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
3/30 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.8%
4/59 • Number of events 6 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
18.4%
25/136 • Number of events 33 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
|
3.1%
2/64 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
3/46 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
2/30 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
3/59 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.3%
14/136 • Number of events 18 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
3/59 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.8%
1/36 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
2/33 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/61 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Skin laceration
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
2/59 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
8/136 • Number of events 10 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
3/136 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
2/59 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
7/136 • Number of events 7 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Weight increased
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
3/64 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/46 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
2/59 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.7%
5/136 • Number of events 5 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
2/30 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
50.0%
1/2 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
|
4.7%
3/64 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
3/64 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
1/23 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.0%
6/46 • Number of events 6 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
3/59 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
8/136 • Number of events 9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Joint stiffness
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Myalgia
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
3.1%
2/64 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.9%
7/64 • Number of events 7 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.0%
3/23 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.7%
4/46 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
3/30 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.8%
4/59 • Number of events 4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.8%
16/136 • Number of events 30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
3/59 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
2/59 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
2/136 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/59 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.74%
1/136 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
2/136 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Endometrial hyperplasia
|
0.00%
0/36 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Endometriosis
|
0.00%
0/36 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Rhinorrhoea
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.7%
2/23 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
3/136 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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
Sinus congestion
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/46 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/59 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/136 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/64 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/23 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
2/59 • Number of events 2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.1%
11/136 • Number of events 12 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Baseline Up To 208 Weeks
All randomized participants who received at least 1 dose of study drug. 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 The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 5 years from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER