Trial Outcomes & Findings for A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (NCT NCT05516758)
NCT ID: NCT05516758
Last Updated: 2025-12-04
Results Overview
The ACR20 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR20 responders were participants with at least 20% improvement from baseline in tender joint count (TJC) and swollen joint count (SJC), and at least 20% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response= (number of ACR20 responders)/ (number of participants analyzed) \*100.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
491 participants
Primary outcome timeframe
Week 12
Results posted on
2025-12-04
Participant Flow
Participant milestones
| Measure |
Peresolimab 1000 mg SC Q4W
Participants received peresolimab 1000 milligram (mg) subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 24. At Week 24, based on their Clinical Disease Activity Index (CDAI) score, participants continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60.
|
Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W
Participants received peresolimab 1000 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 1000 mg SC once every 12 weeks (Q12W) from Week 24 to Week 60.
|
Peresolimab 400 mg SC Q4W
Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants continued peresolimab 400 mg SC Q4W from Week 24 to Week 60.
|
Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W
Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60.
|
Peresolimab 100 mg SC Q4W
Participants received peresolimab 100 mg SC Q4W from Week 0 to Week 60.
|
Placebo SC Q4W to Peresolimab 1000 mg SC Q4W
Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60.
|
Placebo SC Q4W to Peresolimab 400 mg SC Q4W
Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
115
|
26
|
116
|
25
|
69
|
73
|
67
|
|
Overall Study
Received Atleast One Dose of Study Drug
|
115
|
26
|
116
|
25
|
68
|
73
|
67
|
|
Overall Study
Peresolimab 1000 mg Q4W (Discontinued Before Week 24)
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Peresolimab 1000 mg Q4W to Peresolimab 1000 mg Q4W
|
103
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Peresolimab 400 mg Q4W (Discontinued Before Week 24)
|
0
|
0
|
22
|
0
|
0
|
0
|
0
|
|
Overall Study
Peresolimab 400 mg Q4W to Peresolimab 400 mg Q4W
|
0
|
0
|
94
|
0
|
0
|
0
|
0
|
|
Overall Study
Placebo SC Q4W Only
|
0
|
0
|
0
|
0
|
0
|
7
|
7
|
|
Overall Study
Placebo SC Q4W to Peresolimab 1000 mg SC Q4W
|
0
|
0
|
0
|
0
|
0
|
66
|
0
|
|
Overall Study
Placebo SC Q4W to Peresolimab 400 mg SC Q4W
|
0
|
0
|
0
|
0
|
0
|
0
|
60
|
|
Overall Study
COMPLETED
|
78
|
23
|
73
|
22
|
48
|
47
|
36
|
|
Overall Study
NOT COMPLETED
|
37
|
3
|
43
|
3
|
21
|
26
|
31
|
Reasons for withdrawal
| Measure |
Peresolimab 1000 mg SC Q4W
Participants received peresolimab 1000 milligram (mg) subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 24. At Week 24, based on their Clinical Disease Activity Index (CDAI) score, participants continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60.
|
Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W
Participants received peresolimab 1000 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 1000 mg SC once every 12 weeks (Q12W) from Week 24 to Week 60.
|
Peresolimab 400 mg SC Q4W
Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants continued peresolimab 400 mg SC Q4W from Week 24 to Week 60.
|
Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W
Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60.
|
Peresolimab 100 mg SC Q4W
Participants received peresolimab 100 mg SC Q4W from Week 0 to Week 60.
|
Placebo SC Q4W to Peresolimab 1000 mg SC Q4W
Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60.
|
Placebo SC Q4W to Peresolimab 400 mg SC Q4W
Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
3
|
0
|
1
|
3
|
5
|
|
Overall Study
Assigned treatment by mistake
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
6
|
0
|
2
|
0
|
3
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
0
|
3
|
2
|
1
|
|
Overall Study
Other- As reported by the site
|
2
|
1
|
8
|
1
|
2
|
3
|
8
|
|
Overall Study
Physician Decision
|
1
|
0
|
7
|
0
|
1
|
1
|
2
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
11
|
1
|
15
|
2
|
7
|
7
|
6
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Non-compliance With Study Drug
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Site Terminated by Sponsor
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
4
|
0
|
3
|
0
|
2
|
3
|
0
|
|
Overall Study
Participants not proceeding to Follow-up phase
|
1
|
0
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Peresolimab 1000 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=68 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
Placebo SC Q4W
n=140 Participants
All participants received peresolimab-matched Placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Total
n=490 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.20 years
STANDARD_DEVIATION 11.73 • n=3 Participants
|
54.50 years
STANDARD_DEVIATION 11.56 • n=3 Participants
|
54.40 years
STANDARD_DEVIATION 12.08 • n=6 Participants
|
54.00 years
STANDARD_DEVIATION 10.15 • n=3 Participants
|
54.00 years
STANDARD_DEVIATION 11.28 • n=15 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=3 Participants
|
119 Participants
n=3 Participants
|
52 Participants
n=6 Participants
|
114 Participants
n=3 Participants
|
404 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=3 Participants
|
22 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
26 Participants
n=3 Participants
|
86 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
72 Participants
n=3 Participants
|
73 Participants
n=3 Participants
|
44 Participants
n=6 Participants
|
78 Participants
n=3 Participants
|
267 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=3 Participants
|
67 Participants
n=3 Participants
|
24 Participants
n=6 Participants
|
57 Participants
n=3 Participants
|
215 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=3 Participants
|
8 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=3 Participants
|
14 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
22 Participants
n=3 Participants
|
52 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=3 Participants
|
17 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
14 Participants
n=3 Participants
|
57 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=3 Participants
|
13 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=3 Participants
|
106 Participants
n=3 Participants
|
54 Participants
n=6 Participants
|
99 Participants
n=3 Participants
|
364 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=15 Participants
|
|
Region of Enrollment
Argentina
|
36 Participants
n=3 Participants
|
39 Participants
n=3 Participants
|
24 Participants
n=6 Participants
|
36 Participants
n=3 Participants
|
135 Participants
n=15 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=15 Participants
|
|
Region of Enrollment
China
|
6 Participants
n=3 Participants
|
8 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=3 Participants
|
25 Participants
n=15 Participants
|
|
Region of Enrollment
Greece
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
|
Region of Enrollment
Hungary
|
11 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
10 Participants
n=3 Participants
|
29 Participants
n=15 Participants
|
|
Region of Enrollment
Japan
|
14 Participants
n=3 Participants
|
9 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=3 Participants
|
32 Participants
n=15 Participants
|
|
Region of Enrollment
Mexico
|
18 Participants
n=3 Participants
|
21 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
27 Participants
n=3 Participants
|
74 Participants
n=15 Participants
|
|
Region of Enrollment
Poland
|
19 Participants
n=3 Participants
|
24 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
12 Participants
n=3 Participants
|
66 Participants
n=15 Participants
|
|
Region of Enrollment
Spain
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=3 Participants
|
12 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=3 Participants
|
30 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
33 Participants
n=3 Participants
|
112 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants who received atleast one dose of study drug. Non-Responder Imputation (NRI) was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
The ACR20 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR20 responders were participants with at least 20% improvement from baseline in tender joint count (TJC) and swollen joint count (SJC), and at least 20% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response= (number of ACR20 responders)/ (number of participants analyzed) \*100.
Outcome measures
| Measure |
Placebo SC Q4W
n=140 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=68 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Response at Week 12
|
39.3 Percentage of Participants
Interval 31.2 to 47.4
|
51.8 Percentage of Participants
Interval 43.5 to 60.0
|
51.1 Percentage of Participants
Interval 42.8 to 59.3
|
44.1 Percentage of Participants
Interval 32.3 to 55.9
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
The ACR50 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR50 responders were participants with at least 50% improvement from baseline in TJC and SJC, and at least 50% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, HAQ-DI which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \* 100.
Outcome measures
| Measure |
Placebo SC Q4W
n=140 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=68 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 12
|
10.7 Percentage of Participants
Interval 5.6 to 15.8
|
22.7 Percentage of Participants
Interval 15.8 to 29.6
|
19.1 Percentage of Participants
Interval 12.7 to 25.6
|
11.8 Percentage of Participants
Interval 4.1 to 19.4
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
The ACR70 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR70 responders were participants with at least 70% improvement from baseline in TJC and SJC, and at least 70% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, HAQ-DI which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \* 100.
Outcome measures
| Measure |
Placebo SC Q4W
n=140 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=68 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70) Response at Week 12
|
2.9 Percentage of Participants
Interval 0.1 to 5.6
|
7.1 Percentage of Participants
Interval 2.9 to 11.3
|
6.4 Percentage of Participants
Interval 2.3 to 10.4
|
7.4 Percentage of Participants
Interval 1.1 to 13.6
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
DAS28-hsCRP LDA was defined as DAS28-hsCRP score of ≤3.2. The Disease Activity Score (DAS) based on 28 joint counts consisted of a composite numerical score derived from the following variables: tender joint count (0 to 28), swollen joint count (0 to 28), high-sensitivity C-reactive protein (hsCRP, mg/mL), and the patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56\*square root (sqrt) (TJC28) plus (+) 0.28\*sqrt (SJC28)+ 0.014\* participant's global assessment of disease activity+ 0.36\*natural log(hsCRP+1) + 0.96. Total Scores ranged from 1.0 to 9.4, with lower scores indicating less disease activity.
Outcome measures
| Measure |
Placebo SC Q4W
n=140 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=68 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP) ≤3.2 at Week 12
|
7.1 Percentage of Participants
Interval 2.9 to 11.4
|
17.7 Percentage of Participants
Interval 11.4 to 24.0
|
17.0 Percentage of Participants
Interval 10.8 to 23.2
|
17.6 Percentage of Participants
Interval 8.6 to 26.7
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
DAS28-hsCRP remission is defined as DAS28-hsCRP \<2.6. DAS based on 28 joints consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP=0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.014\* patient's global assessment of disease activity + 0.36\*natural log(hsCRP+1) +0.96. Total Scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Outcome measures
| Measure |
Placebo SC Q4W
n=140 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=68 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Percentage of Participants With Remission According to DAS28-hsCRP Score <2.6 at Week 12
|
4.3 Percentage of Participants
Interval 0.9 to 7.6
|
11.3 Percentage of Participants
Interval 6.1 to 16.6
|
9.9 Percentage of Participants
Interval 5.0 to 14.9
|
5.9 Percentage of Participants
Interval 0.3 to 11.5
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
Low disease activity was defined as a CDAI score of ≤10. CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.
Outcome measures
| Measure |
Placebo SC Q4W
n=140 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=68 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving LDA According to Clinical Disease Activity Index (CDAI) Score ≤10 at Week 12
|
12.1 Percentage of Participants
Interval 6.7 to 17.6
|
22.7 Percentage of Participants
Interval 15.8 to 29.6
|
20.6 Percentage of Participants
Interval 13.9 to 27.2
|
17.6 Percentage of Participants
Interval 8.6 to 26.7
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received atleast one dose of study drug. NRI was applied for participants who had missing data, used rescue or prohibited medication or early discontinued from study or study intervention before or at Week 12. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
Remission was defined as a CDAI score of ≤2.8. CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.
Outcome measures
| Measure |
Placebo SC Q4W
n=140 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=141 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=68 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Remission According to CDAI Score ≤2.8 at Week 12
|
1.4 Percentage of Participants
Interval 0.0 to 3.4
|
2.8 Percentage of Participants
Interval 0.1 to 5.6
|
5.7 Percentage of Participants
Interval 1.9 to 9.5
|
1.5 Percentage of Participants
Interval 0.0 to 4.3
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received atleast one dose of study drug and had data for DAS28-hsCRP. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
DAS based on 28 joints consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP = 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28)+ 0.014\* patient's global assessment of disease activity + 0.36\*natural log(hsCRP+1) +0.96. Total scores ranged 1.0-9.4; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) with treatment, stratification factors, baseline value, visit, treatment-by-visit interaction as fixed factors and participant as a random factor.
Outcome measures
| Measure |
Placebo SC Q4W
n=126 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=133 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=123 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=66 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Change From Baseline in DAS28-hsCRP Score at Week 12
|
-1.08 Units on a scale
Interval -1.3 to -0.85
|
-1.67 Units on a scale
Interval -1.89 to -1.46
|
-1.41 Units on a scale
Interval -1.63 to -1.19
|
-1.29 Units on a scale
Interval -1.59 to -0.99
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received atleast one dose of study drug and had data for CDAI. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity(scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity).CDAI is calculated by summing values of 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. Negative change from baseline indicates improvement. LS Mean was calculated using MMRM with treatment, stratification factors, baseline value, visit, treatment-by-visit interaction as fixed factors and participant as a random factor.
Outcome measures
| Measure |
Placebo SC Q4W
n=125 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=131 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=123 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=65 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI Score at Week 12
|
-14.04 units on a scale
Interval -16.48 to -11.6
|
-19.98 units on a scale
Interval -22.34 to -17.63
|
-17.20 units on a scale
Interval -19.64 to -14.77
|
-15.42 units on a scale
Interval -18.63 to -12.21
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received atleast one dose of study drug and had data for HAQ-DI outcome. As pre-specified in the SAP, participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 12 (Placebo) and Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups).
HAQ-DI was a patient-reported questionnaire used in rheumatoid arthritis to assess physical function over the past week. It covered 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Total score was computed as the sum of domain scores and divided by the number of domains answered. The total score ranges from 0 to 3, with higher scores indicating greater physical limitations. LS Mean was calculated using MMRM with treatment, stratification factors, baseline value, visit and treatment-by-visit interaction as fixed effects and participant as a random effect.
Outcome measures
| Measure |
Placebo SC Q4W
n=127 Participants
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=135 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=131 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=67 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Change From Baseline in HAQ-DI Score at Week 12
|
-0.26 units on a scale
Interval -0.36 to -0.17
|
-0.44 units on a scale
Interval -0.53 to -0.35
|
-0.42 units on a scale
Interval -0.51 to -0.32
|
-0.23 units on a scale
Interval -0.35 to -0.1
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants who received atleast one dose of study drug and had TE-ADA data for this outcome. Participants receiving the same initial treatment were grouped together based on treatment from Week 0 to Week 24 (Peresolimab 1000 mg and 400 mg groups). No study participant treated with peresolimab 1000 mg Q4W had a positive TE-ADA result up to Week 12; thus, zero participants analyzed and no data were collected.
Minimum observed concentration of peresolimab was assessed and stratified by Treatment-Emergent Anti-Drug Antibody (TE-ADA) status (TE ADA positive and TE ADA negative). A TE ADA evaluable participant was defined as TE ADA positive if they met the following criteria: 1. Had baseline status of ADA Not Present and at least 1 postbaseline status of ADA Present with titer ≥ 2×minimum required dilution (MRD) of the ADA assay (Treatment Induced TE ADA). The MRD of peresolimab is 1:10. 2. Had baseline and postbaseline status of ADA Present, with the postbaseline titer being 2 dilutions (4-fold) greater than the baseline titer. TE-ADA negative participants were defined as those not meeting the TE ADA positive criteria.
Outcome measures
| Measure |
Placebo SC Q4W
All participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 were grouped together and reported.
|
Peresolimab 1000 mg SC Q4W
n=130 Participants
All participants who initially received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 400 mg SC Q4W
n=126 Participants
All participants who initially received peresolimab 400 mg SC Q4W from Week 0 to Week 24 were grouped together and reported.
|
Peresolimab 100 mg SC Q4W
n=61 Participants
All participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported.
|
|---|---|---|---|---|
|
Minimum Observed Concentration of Peresolimab by Treatment-Emergent Anti-Drug Antibody (TE ADA) Status
TE-ADA Positive
|
—
|
—
|
2060 nanograms per milliliter
Geometric Coefficient of Variation 28
|
487 nanograms per milliliter
Geometric Coefficient of Variation 248
|
|
Minimum Observed Concentration of Peresolimab by Treatment-Emergent Anti-Drug Antibody (TE ADA) Status
TE-ADA Negative
|
—
|
14700 nanograms per milliliter
Geometric Coefficient of Variation 113
|
4800 nanograms per milliliter
Geometric Coefficient of Variation 155
|
1150 nanograms per milliliter
Geometric Coefficient of Variation 152
|
Adverse Events
Peresolimab 1000 mg SC Q4W (Discontinued Before Week 24)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q4W
Serious events: 11 serious events
Other events: 70 other events
Deaths: 1 deaths
Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Peresolimab 400 mg SC Q4W (Discontinued Before Week 24)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q4W
Serious events: 8 serious events
Other events: 60 other events
Deaths: 0 deaths
Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Peresolimab 100 mg SC Q4W
Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo SC Q4W Only
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo SC Q4W to Peresolimab 1000 mg SC Q4W
Serious events: 7 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo SC Q4W to Peresolimab 400 mg SC Q4W
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peresolimab 1000 mg SC Q4W (Discontinued Before Week 24)
n=12 participants at risk
Participants who received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 (discontinued before Week 24) were reported under this group.
|
Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q4W
n=103 participants at risk
Participants who received peresolimab 1000 mg SC Q4W from Week 0 to Week 24, then continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60 were reported under this group.
|
Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W
n=26 participants at risk
Participants who received peresolimab 1000 mg SC Q4W from Week 0 to Week 24, then switched to peresolimab 1000 mg SC Q12W from Week 24 to Week 60 were reported under this group.
|
Peresolimab 400 mg SC Q4W (Discontinued Before Week 24)
n=22 participants at risk
Participants who received peresolimab 400 mg SC Q4W from Week 0 to Week 24 (discontinued before Week 24) were reported under this group.
|
Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q4W
n=94 participants at risk
Participants who received peresolimab 400 mg SC Q4W from Week 0 to Week 24, then continued peresolimab 400 mg SC Q4W from Week 24 to Week 60 were reported under this group.
|
Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W
n=25 participants at risk
Participants who received peresolimab 400 mg SC Q4W from Week 0 to Week 24, then switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60 were reported under this group.
|
Peresolimab 100 mg SC Q4W
n=68 participants at risk
Participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported under this group.
|
Placebo SC Q4W Only
n=14 participants at risk
Participants who received peresolimab matched Placebo SC Q4W only from Week 0 to Week 12 were reported under this group.
|
Placebo SC Q4W to Peresolimab 1000 mg SC Q4W
n=66 participants at risk
Participants who received peresolimab-matched Placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60 were reported under this group.
|
Placebo SC Q4W to Peresolimab 400 mg SC Q4W
n=60 participants at risk
Participants who received peresolimab-matched Placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60 were reported under this group.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Granuloma
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Cardiac contusion
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Cervical vertebral fracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Femoral neck fracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Fracture displacement
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Splenic injury
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Subdural haematoma
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Arthropathy
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Elbow deformity
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Osteoporotic fracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Rheumatoid arthritis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Adenocarcinoma of colon
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Basal cell carcinoma
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Breast cancer
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Cervix carcinoma
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Fibroadenoma of breast
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Hepatocellular carcinoma
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage iv
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Ovarian adenoma
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Ovarian cancer stage iii
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/89 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebrovascular accident
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Endometriosis
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/89 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 embolism
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Peresolimab 1000 mg SC Q4W (Discontinued Before Week 24)
n=12 participants at risk
Participants who received peresolimab 1000 mg SC Q4W from Week 0 to Week 24 (discontinued before Week 24) were reported under this group.
|
Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q4W
n=103 participants at risk
Participants who received peresolimab 1000 mg SC Q4W from Week 0 to Week 24, then continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60 were reported under this group.
|
Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W
n=26 participants at risk
Participants who received peresolimab 1000 mg SC Q4W from Week 0 to Week 24, then switched to peresolimab 1000 mg SC Q12W from Week 24 to Week 60 were reported under this group.
|
Peresolimab 400 mg SC Q4W (Discontinued Before Week 24)
n=22 participants at risk
Participants who received peresolimab 400 mg SC Q4W from Week 0 to Week 24 (discontinued before Week 24) were reported under this group.
|
Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q4W
n=94 participants at risk
Participants who received peresolimab 400 mg SC Q4W from Week 0 to Week 24, then continued peresolimab 400 mg SC Q4W from Week 24 to Week 60 were reported under this group.
|
Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W
n=25 participants at risk
Participants who received peresolimab 400 mg SC Q4W from Week 0 to Week 24, then switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60 were reported under this group.
|
Peresolimab 100 mg SC Q4W
n=68 participants at risk
Participants who received peresolimab 100 mg SC Q4W from Week 0 to Week 60 were reported under this group.
|
Placebo SC Q4W Only
n=14 participants at risk
Participants who received peresolimab matched Placebo SC Q4W only from Week 0 to Week 12 were reported under this group.
|
Placebo SC Q4W to Peresolimab 1000 mg SC Q4W
n=66 participants at risk
Participants who received peresolimab-matched Placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60 were reported under this group.
|
Placebo SC Q4W to Peresolimab 400 mg SC Q4W
n=60 participants at risk
Participants who received peresolimab-matched Placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60 were reported under this group.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Electrocardiogram st segment abnormal
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Liver function test increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Staphylococcus test positive
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Transaminases increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Urinary occult blood positive
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.0%
2/25 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
3/103 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
3/103 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
3/68 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Bursitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Fibromyalgia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Foot deformity
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Greater trochanteric pain syndrome
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Lumbar spinal stenosis
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Muscular weakness
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Myalgia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Osteolysis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Osteonecrosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Osteoporosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Pathological fracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Rheumatoid arthritis
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
3/68 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Rheumatoid nodule
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Spinal osteoarthritis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Spondylolisthesis
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Trigger finger
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Adenosis sclerosing
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Blepharal papilloma
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Endometriosis
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/89 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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)
Ependymoma
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/89 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
1/56 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
4/60 • Number of events 5 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
1/56 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.8%
6/103 • Number of events 7 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
4/94 • Number of events 5 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
3/68 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Eosinophilia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Iron deficiency anaemia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Leukocytosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Leukopenia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.3%
2/14 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Thrombocytopenia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial escape rhythm
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Left atrial enlargement
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Pulmonary valve incompetence
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 positional
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Blepharitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Diplopia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Episcleritis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eye discharge
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Keratitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Scleritis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Atrophic glossitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.9%
5/103 • Number of events 5 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
3/94 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
4/68 • Number of events 5 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enteritis
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
4/60 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lip erosion
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
3/94 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Drug intolerance
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Dystrophic calcification
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Feeling abnormal
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fibrosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site papule
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.8%
6/103 • Number of events 8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 5 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/60 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site urticaria
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Lithiasis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Malaise
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Necrosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Nodule
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
3/103 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.1%
2/22 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
3/68 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Biliary dyspepsia
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
3/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Metabolic dysfunction-associated liver disease
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Mite allergy
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/44 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/89 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
6/94 • Number of events 6 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cervicitis
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/89 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.8%
6/103 • Number of events 6 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
6/94 • Number of events 6 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.1%
6/66 • Number of events 7 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
3/60 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
4/103 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Furuncle
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis astroviral
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
3/68 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
3/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.8%
6/103 • Number of events 6 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.5%
3/26 • Number of events 8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
3/94 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
6/68 • Number of events 7 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
3/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Otitis media
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
4/103 • Number of events 6 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
3/94 • Number of events 6 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/60 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
2/26 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
3/94 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.8%
7/103 • Number of events 8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
5/94 • Number of events 8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.2%
9/68 • Number of events 11 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
3/66 • Number of events 9 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.3%
5/60 • Number of events 6 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.7%
10/103 • Number of events 12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.5%
8/94 • Number of events 10 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.0%
2/25 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
6/68 • Number of events 7 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
3/66 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
3/60 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
1/79 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Bone contusion
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Fall
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Fracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Fracture displacement
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Hand fracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Immunisation reaction
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Joint dislocation
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Ligament sprain
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Lipohaemarthrosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Meniscus injury
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Radius fracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Road traffic accident
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 wound
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Spinal column injury
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Spinal compression fracture
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Tendon injury
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Tibia fracture
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 ulcer
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Wound
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
3/94 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood potassium increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood urea increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood urine present
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Carotid intima-media thickness increased
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram pr shortened
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Genital haemorrhage
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Intermenstrual bleeding
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/89 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Uterine haemorrhage
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Bronchospasm
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Catarrh
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
3/103 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Obstructive sleep apnoea syndrome
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 mass
|
8.3%
1/12 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Sleep apnoea syndrome
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
2/94 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Wheezing
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Blister
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
3/68 • Number of events 4 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 acneiform
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Eczema
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Erythema
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Neurodermatitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Photosensitivity reaction
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
1/25 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
2/68 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 macular
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
2/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 pruritic
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 lesion
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 ulcer
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
Superficial inflammatory dermatosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/79 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.1%
1/14 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Mass excision
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Pacemaker generated rhythm
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Turbinectomy
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
0.00%
0/8 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
1/79 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/56 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
3/103 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
2/26 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.1%
2/22 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
3/94 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.4%
3/68 • Number of events 3 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.0%
2/66 • Number of events 2 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
1/94 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/66 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/12 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/103 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/26 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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 up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/94 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/68 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/14 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
1/66 • Number of events 1 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/60 • Baseline up to end of follow-up (up to 72 weeks)
All randomized participants from the safety population. 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