Trial Outcomes & Findings for A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis (NCT NCT05911841)
NCT ID: NCT05911841
Last Updated: 2025-12-02
Results Overview
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
234 participants
Primary outcome timeframe
Week 16
Results posted on
2025-12-02
Participant Flow
Induction Period (16 weeks): Participants were randomly assigned to receive 75 mg or 300 mg or 800 mg of LY3454738 or placebo every 2 weeks (Q2W) subcutaneously (SC). Maintenance Period (28 weeks): At Week 16, participants who achieved a ≥50% improvement in EASI \[EASI-50\]) (responders) were reassigned as follows, continuing treatment through Week 40: • Responders from the 800 mg Q2W group were re-randomized to receive either 800 mg LY3454738 every 4 weeks (Q4W) or placebo Q4W. (continued)
* Responders from 300 mg Q2W arm received 300 mg LY3454738 Q4W. * Responders from 75 mg Q2W arm received 150 mg LY3454738 Q4W. * Responders from placebo Q2W arm received placebo Q4W. Escape Arm: Participants who didn't achieve EASI-50 at Week 16 (induction non-responders) or who didn't achieve ≥25% improvement from baseline in EASI at Week 20, 24, 28, 32, or 36 (maintenance non-responders) were assigned to Escape Arm. These participants received LY3454738 800 mg Q4W through Week 40.
Participant milestones
| Measure |
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
|
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Maintenance Period - Placebo Q2W to Placebo Q4W
Maintenance Period (Week 16 - Week 44): Participants received Placebo administered SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 75 mg Q2W to LY3454738 150 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 150 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 300 mg Q2W to LY3454738 300 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 300 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 800 mg Q2W to LY3454738 800 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 800 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 800 mg Q2W to Placebo Q4W
Maintenance Period (Week 16 - Week 44): Participants received Placebo SC Q4W from Week 16 to Week 40.
|
Escape Period - LY3454738 800 mg Q4W
Participants received 800 mg LY3454738 administered SC Q4W through Week 44.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period
STARTED
|
65
|
31
|
45
|
93
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Received At Least One Dose of Study Drug
|
65
|
31
|
45
|
93
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
COMPLETED
|
53
|
26
|
21
|
76
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
NOT COMPLETED
|
12
|
5
|
24
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
STARTED
|
0
|
0
|
0
|
0
|
22
|
13
|
8
|
20
|
19
|
0
|
|
Maintenance Period
Received At Least One Dose of Study Drug
|
0
|
0
|
0
|
0
|
22
|
13
|
8
|
20
|
19
|
0
|
|
Maintenance Period
COMPLETED
|
0
|
0
|
0
|
0
|
10
|
7
|
3
|
7
|
8
|
0
|
|
Maintenance Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
12
|
6
|
5
|
13
|
11
|
0
|
|
Escape Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
105
|
|
Escape Period
Received At Least One Dose of Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
105
|
|
Escape Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
23
|
|
Escape Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
82
|
Reasons for withdrawal
| Measure |
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
|
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Maintenance Period - Placebo Q2W to Placebo Q4W
Maintenance Period (Week 16 - Week 44): Participants received Placebo administered SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 75 mg Q2W to LY3454738 150 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 150 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 300 mg Q2W to LY3454738 300 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 300 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 800 mg Q2W to LY3454738 800 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 800 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 800 mg Q2W to Placebo Q4W
Maintenance Period (Week 16 - Week 44): Participants received Placebo SC Q4W from Week 16 to Week 40.
|
Escape Period - LY3454738 800 mg Q4W
Participants received 800 mg LY3454738 administered SC Q4W through Week 44.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period
Study Terminated by Sponsor
|
2
|
0
|
14
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Withdrawal by Subject
|
4
|
3
|
4
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Lack of Efficacy
|
3
|
0
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Adverse Event
|
3
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Assigned Treatment by Mistake
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Enrolled to Escape Arm
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
4
|
4
|
0
|
|
Maintenance Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
11
|
5
|
1
|
7
|
7
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Maintenance Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Escape Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Escape Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
31
|
|
Escape Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Escape Period
Discontinued Due to Failure to Achieve an EASI-50 Response
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
|
Escape Period
Site Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Escape Period
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
34
|
|
Escape Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
Baseline Characteristics
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Induction - Placebo Q2W
n=65 Participants
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
|
Induction - LY3454738 75 mg Q2W
n=31 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=45 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=93 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 13.4 • n=121 Participants
|
37.3 years
STANDARD_DEVIATION 12.4 • n=122 Participants
|
36.1 years
STANDARD_DEVIATION 13.9 • n=243 Participants
|
35.2 years
STANDARD_DEVIATION 12.6 • n=24 Participants
|
36.4 years
STANDARD_DEVIATION 13.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=121 Participants
|
13 Participants
n=122 Participants
|
21 Participants
n=243 Participants
|
39 Participants
n=24 Participants
|
101 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=121 Participants
|
18 Participants
n=122 Participants
|
24 Participants
n=243 Participants
|
54 Participants
n=24 Participants
|
133 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=121 Participants
|
7 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
12 Participants
n=24 Participants
|
28 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=121 Participants
|
24 Participants
n=122 Participants
|
40 Participants
n=243 Participants
|
80 Participants
n=24 Participants
|
201 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=121 Participants
|
5 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
5 Participants
n=24 Participants
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=121 Participants
|
12 Participants
n=122 Participants
|
25 Participants
n=243 Participants
|
49 Participants
n=24 Participants
|
113 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=121 Participants
|
13 Participants
n=122 Participants
|
14 Participants
n=243 Participants
|
37 Participants
n=24 Participants
|
90 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=121 Participants
|
3 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
9 Participants
n=24 Participants
|
23 Participants
n=99 Participants
|
|
Region of Enrollment
South Korea
|
3 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
9 Participants
n=243 Participants
|
10 Participants
n=24 Participants
|
23 Participants
n=99 Participants
|
|
Region of Enrollment
Hungary
|
3 Participants
n=121 Participants
|
3 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
5 Participants
n=24 Participants
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=121 Participants
|
3 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
9 Participants
n=24 Participants
|
31 Participants
n=99 Participants
|
|
Region of Enrollment
China
|
4 Participants
n=121 Participants
|
4 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
8 Participants
n=24 Participants
|
17 Participants
n=99 Participants
|
|
Region of Enrollment
Japan
|
8 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
9 Participants
n=243 Participants
|
13 Participants
n=24 Participants
|
32 Participants
n=99 Participants
|
|
Region of Enrollment
Taiwan
|
8 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
11 Participants
n=24 Participants
|
25 Participants
n=99 Participants
|
|
Region of Enrollment
Poland
|
17 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
8 Participants
n=243 Participants
|
22 Participants
n=24 Participants
|
53 Participants
n=99 Participants
|
|
Region of Enrollment
Mexico
|
4 Participants
n=121 Participants
|
7 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
6 Participants
n=24 Participants
|
19 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least 1 dose of study drug.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=30 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=29 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=60 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=35 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Percentage of Biologic and Small Molecule Naive Participants Achieving Eczema Area and Severity Index (EASI) 75 (≥75% Reduction in EASI Score) at Week 16
|
20.0 Percentage of participants
|
17.2 Percentage of participants
|
18.3 Percentage of participants
|
14.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-50 responder is defined as a participant who achieves a ≥ 50% reduction from baseline in the EASI score.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=30 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=29 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=60 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=35 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-50 (≥ 50% Reduction in EASI Score) at Week 16
|
40.0 Percentage of participants
|
24.1 Percentage of participants
|
45.0 Percentage of participants
|
28.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=30 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=29 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=60 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=35 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-90 (≥ 90% Reduction in EASI Score) at Week 16
|
3.3 Percentage of participants
|
10.3 Percentage of participants
|
11.7 Percentage of participants
|
8.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=30 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=29 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=60 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=35 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Percentage of Biologic and Small Molecule Naive Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75 at Week 16
|
3.3 Percentage of participants
|
3.4 Percentage of participants
|
6.7 Percentage of participants
|
5.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the SCORAD score.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=30 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=29 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=60 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=35 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Percentage of Biologic and Small Molecule Naive Participants Achieving SCORAD-90 at Week 16
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
1.7 Percentage of participants
|
2.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
vIGA-AD is a standardized clinical tool used to measure the severity of AD. It is a static 5-point scale ranging from 0 to 4, used to grade overall disease severity. Higher viGA-AD scores represent more severe disease. The scale is as below: * 0-Clear: No inflammatory signs of atopic dermatitis (erythema, induration/papulation, lichenification, oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present. * 1-Almost Clear: Barely perceptible erythema, induration/papulation, and/or lichenification. No oozing/crusting. * 2-Mild: Slight but definite erythema (pink), induration/papulation, and/or lichenification. No oozing/crusting. * 3-Moderate: Clearly perceptible erythema (dull red), induration/papulation, and/or lichenification. Oozing and crusting may be present. * 4-Severe: Marked erythema (deep or bright red), induration/papulation, and/or lichenification. Disease is widespread in extent. Oozing or crusting may be present.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=30 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=29 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=60 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=35 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Percentage of Biologic and Small Molecule Naive Participants Achieving Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 at Week 16
|
6.7 Percentage of participants
|
6.9 Percentage of participants
|
15.0 Percentage of participants
|
8.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug in the subset of participants with ≥4-point Itch NRS at baseline.
Percentage of biologic and small molecule naive participants achieving ≥4-point improvement from baseline in Itch NRS in the Subset of biologic and small molecule naive participants with ≥4-point Itch NRS at Baseline were reported. The Itch NRS is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=25 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=19 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=44 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=31 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Percentage of Biologic and Small Molecule Naive Participants Achieving ≥4-point Improvement From Baseline in Itch Numeric Rating Scale (NRS) in the Subset of Biologic and Small Molecule Naive Participants With ≥4-point Itch NRS at Baseline
|
24.0 Percentage of participants
|
5.3 Percentage of participants
|
6.8 Percentage of participants
|
12.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
Mean percent change from baseline in EASI in biologic and small molecule naive participants was reported.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=30 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=29 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=60 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=35 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Mean Percent Change From Baseline in EASI in Biologic and Small Molecule Naive Participants
|
-37.2 Percent change
Standard Error 6.39
|
-25.3 Percent change
Standard Error 6.83
|
-40.1 Percent change
Standard Error 4.76
|
-25.2 Percent change
Standard Error 7.10
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
Mean percent change from baseline in SCORAD in biologic and small molecule naive participants was reported.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=30 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=29 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=60 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=35 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Mean Percent Change From Baseline in SCORAD in Biologic and Small Molecule Naive Participants
|
-21.0 Percent change
Standard Error 4.65
|
-15.2 Percent change
Standard Error 5.01
|
-26.6 Percent change
Standard Error 3.58
|
-16.6 Percent change
Standard Error 4.86
|
SECONDARY outcome
Timeframe: Week 16Population: All biologic and small-molecule-experienced participants who were randomly assigned to study intervention and took at least 1 dose of study drug.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=1 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=16 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=33 Participants
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=30 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Percentage of Biologic and Small Molecule Experienced Participants Achieving EASI-75 at Week 16
|
0.0 Percentage of participants
|
6.2 Percentage of participants
|
12.1 Percentage of participants
|
20.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 113 post Day 1 DosePopulation: All biologic and/or small molecule experienced or biologic-and-small-molecule naïve participants who were randomly assigned to study intervention and took at least 1 dose of LY3454738 and had evaluable PK data.
PK: Serum trough concentrations of LY3454738 were reported.
Outcome measures
| Measure |
Induction - LY3454738 75 mg Q2W
n=22 Participants
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=77 Participants
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
LY3454738 75 mg
n=26 Participants
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738 at Week 16
|
56.2 micrograms per milliliter (μg/mL)
Standard Deviation 18.5
|
151 micrograms per milliliter (μg/mL)
Standard Deviation 56.2
|
—
|
12.1 micrograms per milliliter (μg/mL)
Standard Deviation 7.01
|
Adverse Events
Induction - Placebo Q2W
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Induction - LY3454738 75 mg Q2W
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Induction - LY3454738 300 mg Q2W
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Induction - LY3454738 800 mg Q2W
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Maintenance Period - Placebo Q2W to Placebo Q4W
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Maintenance Period - LY3454738 75 mg Q2W to LY3454738 150 mg Q4W
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Maintenance Period - LY3454738 300 mg Q2W to LY3454738 300 mg Q4W
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Maintenance Period - LY3454738 800 mg Q2W to LY3454738 800 mg Q4W
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Maintenance Period - LY3454738 800 mg Q2W to Placebo Q4W
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Escape Period - LY3454738 800 mg Q4W
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction - Placebo Q2W
n=65 participants at risk
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
|
Induction - LY3454738 75 mg Q2W
n=31 participants at risk
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=45 participants at risk
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=93 participants at risk
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Maintenance Period - Placebo Q2W to Placebo Q4W
n=22 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received Placebo administered SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 75 mg Q2W to LY3454738 150 mg Q4W
n=13 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received 150 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 300 mg Q2W to LY3454738 300 mg Q4W
n=8 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received 300 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 800 mg Q2W to LY3454738 800 mg Q4W
n=20 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received 800 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 800 mg Q2W to Placebo Q4W
n=19 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received Placebo SC Q4W from Week 16 to Week 40.
|
Escape Period - LY3454738 800 mg Q4W
n=105 participants at risk
Participants received 800 mg LY3454738 administered SC Q4W through Week 44.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Traumatic pain
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Rotator cuff syndrome
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Product Issues
Device dislocation
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Chronic obstructive pulmonary disease
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Nasal septum deviation
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 atopic
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 Q2W
n=65 participants at risk
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
|
Induction - LY3454738 75 mg Q2W
n=31 participants at risk
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 300 mg Q2W
n=45 participants at risk
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Induction - LY3454738 800 mg Q2W
n=93 participants at risk
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
|
Maintenance Period - Placebo Q2W to Placebo Q4W
n=22 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received Placebo administered SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 75 mg Q2W to LY3454738 150 mg Q4W
n=13 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received 150 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 300 mg Q2W to LY3454738 300 mg Q4W
n=8 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received 300 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 800 mg Q2W to LY3454738 800 mg Q4W
n=20 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received 800 mg LY3454738 SC Q4W from Week 16 to Week 40.
|
Maintenance Period - LY3454738 800 mg Q2W to Placebo Q4W
n=19 participants at risk
Maintenance Period (Week 16 - Week 44): Participants received Placebo SC Q4W from Week 16 to Week 40.
|
Escape Period - LY3454738 800 mg Q4W
n=105 participants at risk
Participants received 800 mg LY3454738 administered SC Q4W through Week 44.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Lymphadenitis
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Lymphadenopathy
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Lymphopenia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Neutropenia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Dry eye
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Lens dislocation
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anorectal polyp
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/105 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Administration site erythema
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Administration site pruritus
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Administration site swelling
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chills
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Condition aggravated
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Hypothermia
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Influenza like illness
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site bruising
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pruritus
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
2/45 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.5%
7/93 • Number of events 11 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
4/105 • Number of events 6 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Oedema
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
3/105 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Atopy
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Food allergy
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Actinomycosis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/28 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/38 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
4.6%
3/65 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/105 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Folliculitis
|
4.6%
3/65 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/105 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Fungal foot infection
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Furuncle
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Impetigo
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Joint abscess
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Laryngitis
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
5/65 • Number of events 5 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.9%
4/31 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
3/45 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.8%
10/93 • Number of events 10 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.6%
3/22 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.0%
3/20 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
4/105 • Number of events 5 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Paronychia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Puncture site infection
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Rash pustular
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/105 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Staphylococcal impetigo
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Subcutaneous abscess
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
6.2%
4/65 • Number of events 5 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.5%
7/93 • Number of events 9 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.6%
3/22 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
4/105 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 bacterial
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/28 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
1/39 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/7 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/38 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Barotitis media
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Chest injury
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Contusion
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Eyelid scar
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Face injury
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Foot fracture
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Post procedural erythema
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 abrasion
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
4.6%
3/65 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood glucose increased
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood pressure increased
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Heart rate increased
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Oesophagogastroscopy
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Protein urine present
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
2/45 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Flank pain
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Intervertebral disc protrusion
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Neck pain
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Osteoarthritis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Synovial cyst
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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)
Fibroma
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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)
Pyogenic granuloma
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/105 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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)
Uterine leiomyoma
|
0.00%
0/28 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/7 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/38 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
6.2%
4/65 • Number of events 8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
2/45 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
6/93 • Number of events 7 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
3/105 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Product Issues
Device dislocation
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Abnormal uterine bleeding
|
0.00%
0/28 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/7 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
1/38 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/28 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/7 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/38 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Allergic sinusitis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
3.1%
2/65 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Dysphonia
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Emphysema
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Lung opacity
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Productive cough
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Pulmonary calcification
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Rhinorrhoea
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 inflammation
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Acne
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Alopecia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Androgenetic alopecia
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Dermal cyst
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 atopic
|
3.1%
2/65 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
3/45 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
4/93 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
3/105 • Number of events 3 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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 contact
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Diffuse alopecia
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Dry skin
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Hand dermatitis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Nail deformation
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Night sweats
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Perioral dermatitis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Pityriasis rosea
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
2/31 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Rash maculo-papular
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Skin burning sensation
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Skin fissures
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
Skin hyperpigmentation
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
1/45 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
1/22 • Number of events 4 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Intra-uterine contraceptive device removal
|
0.00%
0/28 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/7 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/5 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
1/38 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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
|
1.5%
1/65 • Number of events 2 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Urinary incontinence surgery
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/93 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/65 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/31 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/45 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/13 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/20 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/19 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/105 • Baseline Through Follow-up (Up To 52 Weeks)
All randomized participants. 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