Trial Outcomes & Findings for A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis (NCT NCT02899988)
NCT ID: NCT02899988
Last Updated: 2020-06-18
Results Overview
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
205 participants
Primary outcome timeframe
Week 16
Results posted on
2020-06-18
Participant Flow
Participant milestones
| Measure |
Induction: Placebo
Induction: Participants received placebo subcutaneously (SC) every 8 weeks (Q8W) during Induction period.
|
Induction: 30 mg Mirikizumab Q8W
Induction: Participants received 30 milligram (mg) mirikizumab SC Q8W during Induction period.
|
Induction:100 mg Mirikizumab Q8W
Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab Q8W
Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
|
Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
Maintenance:
Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.
Participants who had greater than or equal to (≥) Psoriasis Area and Severity Index (PASI) 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
|
Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
Maintenance:
Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
|
Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
Maintenance:
Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
|
Maintenance: Placebo to 300 mg Mirikizumab Q8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.
Follow-up: Participants did not receive drug during the follow-up period.
|
Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had less than (\<) PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
Follow-up: Participants did not receive drug during the follow-up period.
|
Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
|
Maintenance: 300 mg Mirikizumab Q8W
Maintenance:
Participants who had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period (16 Weeks)
STARTED
|
52
|
51
|
51
|
51
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Received at Least One Dose of Study Drug
|
52
|
51
|
51
|
51
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
COMPLETED
|
50
|
49
|
51
|
49
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
NOT COMPLETED
|
2
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (88 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
15
|
30
|
34
|
50
|
34
|
21
|
15
|
|
Maintenance Period (88 Weeks)
Rescue Participants
|
0
|
0
|
0
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (88 Weeks)
Roll Over to AMAH (NCT03556202)
|
0
|
0
|
0
|
13
|
9
|
18
|
26
|
42
|
24
|
17
|
0
|
|
Maintenance Period (88 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
13
|
27
|
30
|
45
|
30
|
19
|
13
|
|
Maintenance Period (88 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
3
|
4
|
5
|
4
|
2
|
2
|
|
Follow-Up (16 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
2
|
4
|
3
|
3
|
6
|
2
|
0
|
|
Follow-Up (16 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
2
|
4
|
3
|
3
|
6
|
2
|
0
|
|
Follow-Up (16 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Induction: Placebo
Induction: Participants received placebo subcutaneously (SC) every 8 weeks (Q8W) during Induction period.
|
Induction: 30 mg Mirikizumab Q8W
Induction: Participants received 30 milligram (mg) mirikizumab SC Q8W during Induction period.
|
Induction:100 mg Mirikizumab Q8W
Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab Q8W
Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
|
Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
Maintenance:
Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.
Participants who had greater than or equal to (≥) Psoriasis Area and Severity Index (PASI) 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
|
Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
Maintenance:
Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
|
Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
Maintenance:
Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
|
Maintenance: Placebo to 300 mg Mirikizumab Q8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.
Follow-up: Participants did not receive drug during the follow-up period.
|
Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had less than (\<) PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
Follow-up: Participants did not receive drug during the follow-up period.
|
Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
|
Maintenance: 300 mg Mirikizumab Q8W
Maintenance:
Participants who had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period (16 Weeks)
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (16 Weeks)
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (88 Weeks)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
2
|
2
|
2
|
1
|
|
Maintenance Period (88 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period (88 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
2
|
2
|
0
|
1
|
Baseline Characteristics
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Induction: Placebo
n=52 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=51 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=51 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=51 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 12.39 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 13.28 • n=7 Participants
|
46.0 years
STANDARD_DEVIATION 13.18 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 13.23 • n=4 Participants
|
47.2 years
STANDARD_DEVIATION 12.99 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
152 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 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
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
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
Canada
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All participants who received at least one dose of study drug.
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Outcome measures
| Measure |
Induction: Placebo
n=52 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=51 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=51 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=51 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab SC Q8W during Induction period.
Participants had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
|
0 percentage of participants
Interval 0.0 to 0.0
|
29.4 percentage of participants
Interval 16.9 to 41.9
|
58.8 percentage of participants
Interval 45.3 to 72.3
|
66.7 percentage of participants
Interval 53.7 to 79.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All participants who received at least one dose of study drug.
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no PsO to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Outcome measures
| Measure |
Induction: Placebo
n=52 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=51 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=51 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=51 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab SC Q8W during Induction period.
Participants had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
|
0 percentage of participants
Interval 0.0 to 0.0
|
15.7 percentage of participants
Interval 5.7 to 25.7
|
31.4 percentage of participants
Interval 18.6 to 44.1
|
31.4 percentage of participants
Interval 18.6 to 44.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All participants who received at least one dose of study drug.
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no PsO to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Outcome measures
| Measure |
Induction: Placebo
n=52 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=51 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=51 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=51 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab SC Q8W during Induction period.
Participants had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
|
3.8 percentage of participants
Interval 0.0 to 9.1
|
52.9 percentage of participants
Interval 39.2 to 66.6
|
78.4 percentage of participants
Interval 67.1 to 89.7
|
74.5 percentage of participants
Interval 62.5 to 86.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: All participants who received at least one dose of drug.
The sPGA is the physician's determination of the participant's PsO lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 16 were considered non-responders for non-responder Imputation (NRI) analysis.
Outcome measures
| Measure |
Induction: Placebo
n=52 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=51 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=51 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=51 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab SC Q8W during Induction period.
Participants had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1
sPGA (0)
|
0 percentage of participants
Interval 0.0 to 0.0
|
15.7 percentage of participants
Interval 5.7 to 25.7
|
31.4 percentage of participants
Interval 18.6 to 44.1
|
31.4 percentage of participants
Interval 18.6 to 44.1
|
—
|
—
|
—
|
|
Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1
sPGA (0/1)
|
1.9 percentage of participants
Interval 0.0 to 5.7
|
37.3 percentage of participants
Interval 24.0 to 50.5
|
70.6 percentage of participants
Interval 58.1 to 83.1
|
68.6 percentage of participants
Interval 55.9 to 81.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All participants who received at least one dose of study drug who had baseline and at least one post-baseline PSS observation.
PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. The total score was calculated by summing the 8 individual items and ranged from 0 to 80, higher scores indicated greater symptom/sign severity. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region \[United States/Outside United States (US/OUS)\], previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = heterogeneous autoregressive.
Outcome measures
| Measure |
Induction: Placebo
n=43 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=43 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=44 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=44 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab SC Q8W during Induction period.
Participants had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score
|
-4.35 units on a scale
Standard Error 2.29
|
-31.19 units on a scale
Standard Error 2.34
|
-42.33 units on a scale
Standard Error 2.37
|
-33.66 units on a scale
Standard Error 2.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All participants who received at least one dose of study drug who had baseline and at least one post-baseline Patient Global Assessment observation.
The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
Outcome measures
| Measure |
Induction: Placebo
n=51 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=48 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=51 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=49 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab SC Q8W during Induction period.
Participants had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|
|
Mean Change (Improvement) From Baseline on the Patient Global Assessment
|
0.35 units on a scale
Standard Error 0.16
|
2.24 units on a scale
Standard Error 0.16
|
2.91 units on a scale
Standard Error 0.16
|
2.82 units on a scale
Standard Error 0.16
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All participants who received at least one dose of study drug who had baseline and at least one post-baseline DLQI observation.
The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
Outcome measures
| Measure |
Induction: Placebo
n=51 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=48 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=51 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=49 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab SC Q8W during Induction period.
Participants had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score
|
-1.07 score on a scale
Standard Error 0.69
|
-9.19 score on a scale
Standard Error 0.71
|
-10.18 score on a scale
Standard Error 0.69
|
-9.64 score on a scale
Standard Error 0.70
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All participants who received at least one dose of study drug with a baseline value and at least 1 post-baseline 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, and 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 the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, geographic region (US/OUS), and previous therapy (yes/no) as fixed factors and baseline value as covariate.
Outcome measures
| Measure |
Induction: Placebo
n=51 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=48 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=51 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=49 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Participants received 300 mg mirikizumab SC Q8W during Induction period.
Participants had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
MCS
|
0.28 score on a scale
Standard Error 0.87
|
2.39 score on a scale
Standard Error 0.90
|
2.74 score on a scale
Standard Error 0.88
|
1.52 score on a scale
Standard Error 0.88
|
—
|
—
|
—
|
|
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
PCS
|
1.23 score on a scale
Standard Error 0.84
|
4.58 score on a scale
Standard Error 0.88
|
4.40 score on a scale
Standard Error 0.85
|
5.09 score on a scale
Standard Error 0.85
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 52, Week 56, Week 64, Week 72, Week 80, Week 88, Week 96, Week 100, Week 104Population: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104
Outcome measures
| Measure |
Induction: Placebo
n=13 Participants
Induction: Placebo administered SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab
n=23 Participants
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 100 mg Mirikizumab
n=33 Participants
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab
n=50 Participants
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
n=34 Participants
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
n=21 Participants
Participants received 300 mg mirikizumab Q8W during the maintenance period.
Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
n=15 Participants
Participants received 300 mg mirikizumab SC Q8W during Induction period.
Participants had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104
|
3.22 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 46.33
|
8.94 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 79.19
|
22.96 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 55.80
|
46.4 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62.8
|
34.83 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 92.13
|
47.66 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 70.08
|
51.30 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43.54
|
Adverse Events
Induction: Placebo
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Induction: 30 mg Mirikizumab Q8W
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Induction:100 mg Mirikizumab Q8W
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Induction: 300 mg Mirikizumab Q8W
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Maintenance: Placebo to 300 mg Mirikizumab Q8W
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Maintenance: 300 mg Mirikizumab Q8W
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
300 mg Mirikizumab Q8W-Rescue
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo to 300 mg Mirikizumab Q8W-Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction: Placebo
n=52 participants at risk
Induction: Participants received placebo SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab Q8W
n=51 participants at risk
Induction: Participants received 30 mg mirikizumab Q8W during Induction period.
|
Induction:100 mg Mirikizumab Q8W
n=51 participants at risk
Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab Q8W
n=51 participants at risk
Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
|
Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
n=15 participants at risk
Maintenance:
Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.
Participants who had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
n=30 participants at risk
Maintenance:
Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
n=34 participants at risk
Maintenance:
Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.
|
Maintenance: Placebo to 300 mg Mirikizumab Q8W
n=50 participants at risk
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.
|
Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
n=34 participants at risk
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
n=21 participants at risk
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
Maintenance: 300 mg Mirikizumab Q8W
n=15 participants at risk
Maintenance:
Participants who had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
300 mg Mirikizumab Q8W-Rescue
n=10 participants at risk
Participants received 300 mg Q8W mirikizumab during rescue.
|
30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up
n=2 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up
n=4 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up
n=3 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
Placebo to 300 mg Mirikizumab Q8W-Follow-up
n=3 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
n=6 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
n=2 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraocular melanoma
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Nasal septal operation
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Induction: Placebo
n=52 participants at risk
Induction: Participants received placebo SC Q8W during Induction period.
|
Induction: 30 mg Mirikizumab Q8W
n=51 participants at risk
Induction: Participants received 30 mg mirikizumab Q8W during Induction period.
|
Induction:100 mg Mirikizumab Q8W
n=51 participants at risk
Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.
|
Induction: 300 mg Mirikizumab Q8W
n=51 participants at risk
Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
|
Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
n=15 participants at risk
Maintenance:
Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.
Participants who had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
n=30 participants at risk
Maintenance:
Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
n=34 participants at risk
Maintenance:
Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.
|
Maintenance: Placebo to 300 mg Mirikizumab Q8W
n=50 participants at risk
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.
|
Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
n=34 participants at risk
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had \< PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
|
Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
n=21 participants at risk
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had \< PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
|
Maintenance: 300 mg Mirikizumab Q8W
n=15 participants at risk
Maintenance:
Participants who had \< PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
|
300 mg Mirikizumab Q8W-Rescue
n=10 participants at risk
Participants received 300 mg Q8W mirikizumab during rescue.
|
30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up
n=2 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up
n=4 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up
n=3 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
Placebo to 300 mg Mirikizumab Q8W-Follow-up
n=3 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
n=6 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
n=2 participants at risk
Follow-up: Participants did not receive drug during the follow-up period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/42 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/35 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/36 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Body tinea
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.3%
2/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.3%
2/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.3%
2/15 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
1.9%
1/52 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 14 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
2/51 • Number of events 9 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 9 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.0%
4/50 • Number of events 92 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 67 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.5%
2/21 • Number of events 31 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.0%
2/10 • Number of events 39 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.5%
2/21 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.0%
3/15 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Ear infection
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.3%
3/21 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hepatitis a
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hepatitis e
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
3/50 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
50.0%
1/2 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
13.5%
7/52 • Number of events 8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.8%
5/51 • Number of events 7 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.8%
6/51 • Number of events 8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.7%
8/51 • Number of events 10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.0%
3/15 • Number of events 8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
3/30 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.6%
7/34 • Number of events 10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
30.0%
15/50 • Number of events 26 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
35.3%
12/34 • Number of events 25 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
23.8%
5/21 • Number of events 13 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
33.3%
5/15 • Number of events 12 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.0%
2/10 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
2/51 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.3%
3/21 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.3%
2/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Skin infection
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
2/52 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.8%
6/51 • Number of events 6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
2/51 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.3%
2/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
5/30 • Number of events 6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.0%
8/50 • Number of events 9 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 7 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
23.8%
5/21 • Number of events 6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urethritis chlamydial
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.0%
4/50 • Number of events 5 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.3%
2/15 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Wound infection
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
3/50 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring 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%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 7 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 5 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 5 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.3%
3/21 • Number of events 5 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Weight increased
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
2/30 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.3%
3/21 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
3/50 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
23.5%
8/34 • Number of events 10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.3%
3/21 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
2/50 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
2/30 • Number of events 5 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
3/50 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/42 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/35 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/36 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/12 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
—
0/0 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
2/30 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.7%
5/34 • Number of events 8 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.3%
2/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
3/50 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.5%
2/21 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
1/30 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/52 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
3/50 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.9%
1/52 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/50 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Tooth extraction
|
3.8%
2/52 • Number of events 2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/30 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/52 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/15 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
3/30 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.0%
4/50 • Number of events 4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
3/34 • Number of events 3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
23.8%
5/21 • Number of events 5 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
1/15 • Number of events 1 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/2 • Up To 120 Weeks
All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60