Trial Outcomes & Findings for A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3) (NCT NCT03556202)
NCT ID: NCT03556202
Last Updated: 2023-03-21
Results Overview
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1936 participants
Primary outcome timeframe
Week 104
Results posted on
2023-03-21
Participant Flow
Participants who completed an originating study: I6T-MC-AMAF (NCT02899988), I6T-MC-AMAK (NCT03482011) and I6T-MC-AMAJ (NCT03535194) were eligible for enrollment into study AMAH.
Participant milestones
| Measure |
125 Milligram (mg) Mirikizumab Q8W
Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
|
250 mg Mirikizumab Q8W Excluding Secukinumab
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Extension Treatment Period
STARTED
|
527
|
1020
|
389
|
|
Extension Treatment Period
Received at Least One Dose of Study Drug
|
527
|
1020
|
389
|
|
Extension Treatment Period
From AMAF
|
35
|
132
|
0
|
|
Extension Treatment Period
From AMAK
|
83
|
390
|
0
|
|
Extension Treatment Period
From AMAJ
|
409
|
498
|
389
|
|
Extension Treatment Period
COMPLETED
|
0
|
0
|
0
|
|
Extension Treatment Period
NOT COMPLETED
|
527
|
1020
|
389
|
|
Follow-Up Period (12 Weeks)
STARTED
|
453
|
861
|
333
|
|
Follow-Up Period (12 Weeks)
COMPLETED
|
0
|
0
|
0
|
|
Follow-Up Period (12 Weeks)
NOT COMPLETED
|
453
|
861
|
333
|
Reasons for withdrawal
| Measure |
125 Milligram (mg) Mirikizumab Q8W
Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
|
250 mg Mirikizumab Q8W Excluding Secukinumab
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Extension Treatment Period
Adverse Event
|
18
|
14
|
9
|
|
Extension Treatment Period
Death
|
2
|
6
|
0
|
|
Extension Treatment Period
Lack of Efficacy
|
5
|
12
|
18
|
|
Extension Treatment Period
Lost to Follow-up
|
9
|
20
|
2
|
|
Extension Treatment Period
Pregnancy
|
2
|
4
|
3
|
|
Extension Treatment Period
Study Terminated by Sponsor
|
469
|
907
|
331
|
|
Extension Treatment Period
Withdrawal by Subject
|
22
|
47
|
22
|
|
Extension Treatment Period
Due to Exclusion Criteria of AMAJ study
|
0
|
0
|
1
|
|
Extension Treatment Period
Physician Decision
|
0
|
8
|
2
|
|
Extension Treatment Period
Protocol Violation
|
0
|
1
|
1
|
|
Extension Treatment Period
Sponsor Decision
|
0
|
1
|
0
|
|
Follow-Up Period (12 Weeks)
Adverse Event
|
11
|
11
|
8
|
|
Follow-Up Period (12 Weeks)
Death
|
1
|
0
|
0
|
|
Follow-Up Period (12 Weeks)
Lack of Efficacy
|
4
|
9
|
13
|
|
Follow-Up Period (12 Weeks)
Lost to Follow-up
|
4
|
14
|
3
|
|
Follow-Up Period (12 Weeks)
Pregnancy
|
1
|
4
|
1
|
|
Follow-Up Period (12 Weeks)
Study Terminated by Sponsor
|
396
|
750
|
273
|
|
Follow-Up Period (12 Weeks)
Withdrawal by Subject
|
36
|
65
|
31
|
|
Follow-Up Period (12 Weeks)
Physician Decision
|
0
|
3
|
1
|
|
Follow-Up Period (12 Weeks)
Site Terminated by Sponsor
|
0
|
1
|
0
|
|
Follow-Up Period (12 Weeks)
Study Discontinued by Sponsor
|
0
|
2
|
1
|
|
Follow-Up Period (12 Weeks)
Second Follow-up Visit: Patient Refused
|
0
|
1
|
0
|
|
Follow-Up Period (12 Weeks)
Study terminated & Subject Missed Follow-up Visit
|
0
|
1
|
0
|
|
Follow-Up Period (12 Weeks)
To Meet Exclusion Criteria of the AMAJ Study
|
0
|
0
|
1
|
|
Follow-Up Period (12 Weeks)
Second Follow-up Not Done, unable to reach Patient
|
0
|
0
|
1
|
Baseline Characteristics
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
Baseline characteristics by cohort
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=527 Participants
Participants received 125 mg mirikizumab administered SC Q8W.
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=1020 Participants
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=389 Participants
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
Total
n=1936 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.90 years
STANDARD_DEVIATION 13.81 • n=5 Participants
|
47.00 years
STANDARD_DEVIATION 12.87 • n=7 Participants
|
46.50 years
STANDARD_DEVIATION 14.41 • n=5 Participants
|
47.10 years
STANDARD_DEVIATION 13.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
578 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
368 Participants
n=5 Participants
|
711 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
1358 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
282 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
419 Participants
n=5 Participants
|
807 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
1542 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
89 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
369 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
415 Participants
n=5 Participants
|
734 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
1464 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
26 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Region of Enrollment
Czechia
|
25 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
65 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
243 Participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
39 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
15 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
75 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
279 Participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
3 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
24 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
9 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
110 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
397 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 104Population: All randomized participants who received at least one dose of drug and who entered Study AMAH with sPGA (0,1).
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.
Outcome measures
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=467 Participants
Participants received 125 mg mirikizumab administered SC Q8W.
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=820 Participants
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=296 Participants
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1
|
46.7 percentage of participants
Interval 42.2 to 51.2
|
55.7 percentage of participants
Interval 52.3 to 59.1
|
38.9 percentage of participants
Interval 33.3 to 44.4
|
PRIMARY outcome
Timeframe: Week 104Population: All randomized participants who received at least one dose of study drug and who entered AMAH with PASI 90 Response.
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Outcome measures
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=460 Participants
Participants received 125 mg mirikizumab administered SC Q8W.
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=813 Participants
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=302 Participants
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90
|
49.3 percentage of participants
Interval 44.8 to 53.9
|
56.8 percentage of participants
Interval 53.4 to 60.2
|
39.4 percentage of participants
Interval 33.9 to 44.9
|
SECONDARY outcome
Timeframe: Week 104Population: All randomized participants who received at least one dose of study drug.
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Outcome measures
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=527 Participants
Participants received 125 mg mirikizumab administered SC Q8W.
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=1020 Participants
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=389 Participants
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
|
30.4 percentage of participants
Interval 26.4 to 34.3
|
36.4 percentage of participants
Interval 33.4 to 39.3
|
22.6 percentage of participants
Interval 18.5 to 26.8
|
SECONDARY outcome
Timeframe: Week 104Population: All randomized participants with PSS symptom score of ≥1 at baseline.
PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported.
Outcome measures
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=518 Participants
Participants received 125 mg mirikizumab administered SC Q8W.
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=1008 Participants
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=376 Participants
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline
|
31.1 percentage of participants
Interval 27.1 to 35.1
|
33.6 percentage of participants
Interval 30.7 to 36.5
|
23.4 percentage of participants
Interval 19.1 to 27.7
|
SECONDARY outcome
Timeframe: Week 104Population: All randomized participants who had a baseline DLQI Total Score ≥5.
The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold.
Outcome measures
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=477 Participants
Participants received 125 mg mirikizumab administered SC Q8W.
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=922 Participants
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=345 Participants
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
|
41.5 percentage of participants
Interval 37.1 to 45.9
|
47.3 percentage of participants
Interval 44.1 to 50.5
|
34.5 percentage of participants
Interval 29.5 to 39.5
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: All randomized participants who had palmoplantar involvement at baseline.
The PPASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.
Outcome measures
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=51 Participants
Participants received 125 mg mirikizumab administered SC Q8W.
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=114 Participants
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=31 Participants
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
|
-6.55 score on a scale
Standard Deviation 7.058
|
-6.80 score on a scale
Standard Deviation 8.391
|
-7.38 score on a scale
Standard Deviation 6.632
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: All randomized participants who had Scalp Involvement at baseline.
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
Outcome measures
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=204 Participants
Participants received 125 mg mirikizumab administered SC Q8W.
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=454 Participants
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=136 Participants
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
|
-20.9 score on a scale
Standard Deviation 15.79
|
-19.5 score on a scale
Standard Deviation 13.48
|
-19.6 score on a scale
Standard Deviation 13.44
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: All randomized participants who had Nail Psoriasis involvement at baseline.
The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).
Outcome measures
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=136 Participants
Participants received 125 mg mirikizumab administered SC Q8W.
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=304 Participants
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=89 Participants
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
|---|---|---|---|
|
Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
|
-19.4 score on a scale
Standard Deviation 17.75
|
-21.0 score on a scale
Standard Deviation 17.69
|
-22.2 score on a scale
Standard Deviation 18.75
|
Adverse Events
125 Milligram (mg) Mirikizumab Q8W
Serious events: 55 serious events
Other events: 388 other events
Deaths: 2 deaths
250 mg Mirikizumab Q8W Excluding Secukinumab
Serious events: 88 serious events
Other events: 756 other events
Deaths: 6 deaths
Secukinumab/250 mg Mirikizumab Q8W
Serious events: 35 serious events
Other events: 288 other events
Deaths: 0 deaths
125 Milligram (mg) Mirikizumab Q8W Follow-up Period
Serious events: 7 serious events
Other events: 70 other events
Deaths: 1 deaths
250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period
Serious events: 6 serious events
Other events: 120 other events
Deaths: 0 deaths
Secukinumab/250 mg Mirikizumab Q8W Follow-up Period
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=527 participants at risk
Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=1020 participants at risk
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=389 participants at risk
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
125 Milligram (mg) Mirikizumab Q8W Follow-up Period
n=453 participants at risk
Participants did not receive any intervention in post- treatment follow-up period.
|
250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period
n=861 participants at risk
Participants did not receive any intervention in post- treatment follow-up period.
|
Secukinumab/250 mg Mirikizumab Q8W Follow-up Period
n=333 participants at risk
Participants did not receive any intervention in post- treatment follow-up period.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Odontogenic cyst
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Primary hyperaldosteronism
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Keratitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Ocular hypertension
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Death
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Gait disturbance
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Gallbladder fistula
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Corneal graft rejection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Campylobacter colitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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 pneumonia
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/711 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Closed globe injury
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Neovaginal complication
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Growth hormone-producing pituitary tumour
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage iii
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/711 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.36%
1/279 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Sedation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Product Issues
Device dislocation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/711 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Blepharoplasty
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Gastric polypectomy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Peripheral revascularisation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Stent placement
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Stent removal
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Embolism
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Haematoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
125 Milligram (mg) Mirikizumab Q8W
n=527 participants at risk
Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
|
250 mg Mirikizumab Q8W Excluding Secukinumab
n=1020 participants at risk
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
|
Secukinumab/250 mg Mirikizumab Q8W
n=389 participants at risk
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
|
125 Milligram (mg) Mirikizumab Q8W Follow-up Period
n=453 participants at risk
Participants did not receive any intervention in post- treatment follow-up period.
|
250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period
n=861 participants at risk
Participants did not receive any intervention in post- treatment follow-up period.
|
Secukinumab/250 mg Mirikizumab Q8W Follow-up Period
n=333 participants at risk
Participants did not receive any intervention in post- treatment follow-up period.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
14/1020 • Number of events 16 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Bone marrow oedema
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.19%
1/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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 left
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Right atrial enlargement
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Sinus bradycardia
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Sinus tachycardia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Block vertebra
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/711 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear inflammation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Eustachian tube obstruction
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.38%
2/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Acromegaly
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral lichen planus
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Goitre
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral papule
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Arteriosclerotic retinopathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Chalazion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Diabetic retinopathy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Dry eye
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eye allergy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eye disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eye irritation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eye pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eyelid thickening
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Glaucoma
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Macular degeneration
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Ocular surface disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Open angle glaucoma
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Optic disc drusen
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Trichiasis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Vitreous detachment
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Vitreous haemorrhage
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Vitreous prolapse
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
13/1020 • Number of events 15 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/389 • Number of events 17 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.57%
3/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
6/389 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 13 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
15/527 • Number of events 15 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
20/1020 • Number of events 21 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
9/389 • Number of events 33 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.35%
3/861 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/333 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/389 • Number of events 16 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Food poisoning
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 19 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.44%
2/453 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Odynophagia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral hyperkeratosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Proctitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
16/1020 • Number of events 19 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
9/389 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chills
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Cyst
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Effusion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.95%
5/527 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/333 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Hyperthermia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Implant site irritation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site bruising
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site discolouration
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 26 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site haematoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site induration
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site inflammation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site oedema
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
1.5%
8/527 • Number of events 79 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
22/1020 • Number of events 283 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
6/389 • Number of events 36 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pruritus
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site rash
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
1.1%
6/527 • Number of events 15 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.9%
19/1020 • Number of events 108 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.9%
19/389 • Number of events 44 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site swelling
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Malaise
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Nodule
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.57%
3/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pain
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Peripheral swelling
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Puncture site pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
2.1%
11/527 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
17/1020 • Number of events 17 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.8%
11/389 • Number of events 13 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
5/453 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Swelling face
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Tenderness
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Ulcer
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Vaccination site joint pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Vaccination site oedema
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Vaccination site pain
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 16 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Vaccination site swelling
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Xerosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Biliary colic
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Fatty liver alcoholic
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Nonalcoholic fatty liver disease
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Primary biliary cholangitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Allergy to animal
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Anaphylactic reaction
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Hypersensitivity
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.95%
5/527 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Acarodermatitis
|
0.38%
2/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Adenoviral conjunctivitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Asymptomatic covid-19
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Body tinea
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
1.9%
10/527 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.4%
24/1020 • Number of events 25 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis bacterial
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Candida infection
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Coronavirus infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Coronavirus pneumonia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
6.3%
33/527 • Number of events 33 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
66/1020 • Number of events 67 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.7%
26/389 • Number of events 28 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.5%
16/453 • Number of events 16 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
11/861 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
6/333 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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 pneumonia
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.57%
3/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.69%
7/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Ear infection
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tooth infection
|
0.76%
4/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.42%
3/711 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Erysipelas
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Erythema migrans
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Erythrasma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Folliculitis
|
1.3%
7/527 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Fungal infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Fungal skin infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Furuncle
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
6/527 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
15/1020 • Number of events 17 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal infection
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Genital infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gingivitis
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Helicobacter infection
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hepatitis a
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpangina
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
1.1%
6/527 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.69%
7/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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 infection neurological
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hordeolum
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Impetigo
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
18/1020 • Number of events 18 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Injection site infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Latent tuberculosis
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Lymphogranuloma venereum
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Mucocutaneous candidiasis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Myringitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
10.4%
55/527 • Number of events 69 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.4%
157/1020 • Number of events 226 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
43/389 • Number of events 57 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
5/453 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
11/861 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
5/333 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Onychomycosis
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
1.3%
7/527 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
11/1020 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Otitis externa
|
0.38%
2/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Otitis media
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Papilloma viral infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Paronychia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Parotitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
1.7%
9/527 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
17/1020 • Number of events 19 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
10/389 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pilonidal cyst
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pulpitis dental
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
11/1020 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Root canal infection
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
1.3%
7/527 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
21/1020 • Number of events 23 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
7/389 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/333 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Skin candida
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Skin infection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Superinfection
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Superinfection mycobacterial
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Suspected covid-19
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Testicular abscess
|
0.27%
1/368 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/711 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tinea cruris
|
0.38%
2/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tinea infection
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tinea pedis
|
0.95%
5/527 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 13 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tinea versicolour
|
0.76%
4/527 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.69%
7/1020 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tonsillitis
|
0.76%
4/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/389 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Trichophytosis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
22/527 • Number of events 29 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.3%
54/1020 • Number of events 64 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.5%
29/389 • Number of events 42 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
5/453 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.58%
5/861 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
4/333 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urethritis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
11/527 • Number of events 14 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
30/1020 • Number of events 38 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
9/389 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.58%
5/861 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vaginal infection
|
0.63%
1/159 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
3/309 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral sinusitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.63%
1/159 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.65%
2/309 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.9%
3/159 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
2/110 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Wound infection
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Bite
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.69%
7/1020 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/389 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.38%
2/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foreign body in throat
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Injury
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.1%
6/527 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
15/1020 • Number of events 15 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/389 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post vaccination syndrome
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.1%
6/527 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.44%
2/453 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Retinal injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Endoscopy upper gastrointestinal tract
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Scar
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.5%
8/527 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.38%
2/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
13/1020 • Number of events 13 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/333 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
9/527 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
23/1020 • Number of events 28 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Arthroscopy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
9/527 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
15/1020 • Number of events 22 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Aspiration joint
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Basophil count increased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Biopsy lymph gland
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Biopsy skin
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.9%
10/527 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
20/1020 • Number of events 25 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
7/389 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/333 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood gastrin increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood glucose increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood iron decreased
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood parathyroid hormone increased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood potassium increased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood pressure abnormal
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood pressure increased
|
0.57%
3/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood triglycerides increased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Body height decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Body temperature increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Bone scan
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Cardiac murmur
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Cardiac stress test
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Chest x-ray
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Colonoscopy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Colonoscopy normal
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Computerised tomogram coronary artery
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Coronavirus test positive
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Culture urine positive
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Echocardiogram
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.7%
9/527 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
21/1020 • Number of events 28 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Haematocrit increased
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Haemoglobin increased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Heart rate decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Heart rate increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Heart rate irregular
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
0.95%
5/527 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
High density lipoprotein increased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Hormone level abnormal
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Influenza a virus test positive
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Intraocular pressure increased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Kl-6 increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Liver function test abnormal
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Lymphocyte count decreased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Lymphocyte morphology abnormal
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Mammogram
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Neutrophil count increased
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Platelet count increased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Podiatric examination normal
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/711 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Protein urine
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Renal function test abnormal
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Sars-cov-2 test positive
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/389 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Serum ferritin decreased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Smear cervix
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Spermatozoa progressive motility abnormal
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/711 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.36%
1/279 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Transaminases increased
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Ultrasound kidney
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Ultrasound scan
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Urine leukocyte esterase
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Urine output decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Vitamin d decreased
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Weight increased
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
11/1020 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.38%
2/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 13 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/333 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Gout
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 13 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 14 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
11/1020 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
17/1020 • Number of events 28 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/389 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
30/527 • Number of events 36 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.5%
87/1020 • Number of events 95 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.9%
19/389 • Number of events 23 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/333 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
25/527 • Number of events 27 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.7%
48/1020 • Number of events 61 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
20/389 • Number of events 22 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.46%
4/861 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.57%
3/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.69%
7/1020 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Ligament pain
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.95%
5/527 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 16 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
6/527 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.78%
8/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
6/527 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
22/1020 • Number of events 28 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
7/389 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
1.7%
9/527 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
10/389 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.69%
7/1020 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.1%
6/527 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.69%
7/1020 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal retrolisthesis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.19%
1/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatobiliary neoplasm
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign vascular neoplasm
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Focal nodular hyperplasia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/711 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.9%
3/159 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
4/309 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Anosmia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Aphasia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cognitive disorder
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
3.4%
18/527 • Number of events 21 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
55/1020 • Number of events 93 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
21/389 • Number of events 32 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.44%
2/453 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.81%
7/861 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/333 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Memory impairment
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Nerve compression
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Pineal gland cyst
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
9/1020 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Seizure
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Transient aphasia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Affective disorder
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Alcohol abuse
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
1.1%
6/527 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
11/1020 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
7/389 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
1.3%
7/527 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Distractibility
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
11/1020 • Number of events 11 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Dental implantation
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Mental fatigue
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Panic attack
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Sleep disorder
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Stress
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
16/527 • Number of events 16 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
28/1020 • Number of events 30 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
8/389 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Glycosuria
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Kidney congestion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal cyst
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Adenomyosis
|
1.3%
2/159 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.27%
1/368 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/711 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.82%
3/368 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.84%
6/711 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.72%
2/279 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast mass
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Cervical cyst
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.97%
3/309 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/711 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Genital erythema
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Genital lesion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.91%
1/110 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.63%
1/159 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.63%
1/159 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.65%
2/309 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.8%
2/110 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Perineal cyst
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough variant asthma
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.63%
1/159 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Premenstrual pain
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.27%
1/368 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/711 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Uterine cervical metaplasia
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulval eczema
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.63%
1/159 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.63%
1/159 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic pharyngitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.95%
5/527 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.69%
7/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal disorder
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.76%
4/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate abnormality
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.57%
3/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.1%
11/1020 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
6/389 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.23%
2/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
15/1020 • Number of events 17 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinonasal obstruction
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.59%
6/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.0%
4/389 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne varioliformis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.19%
1/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.76%
4/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.3%
5/389 • Number of events 8 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis papillaris capillitii
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.57%
3/527 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.98%
10/1020 • Number of events 10 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.77%
3/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Itching scar
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Lichenification
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Mechanical urticaria
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
12/527 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
17/1020 • Number of events 20 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.5%
6/389 • Number of events 7 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.38%
2/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
4/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.95%
5/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
12/1020 • Number of events 12 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria physical
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Abscess drainage
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Acrochordon excision
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Ankle operation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cardioversion
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 4 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cataract operation
|
0.38%
2/527 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Circumcision
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/711 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Corneal transplant
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Dental care
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Endoscopic sleeve gastroplasty
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Eyelid cyst removal
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Finger amputation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Hernia hiatus repair
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Hernia repair
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/309 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.39%
1/259 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Internal fixation of fracture
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Intra-uterine contraceptive device insertion
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.38%
2/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Laparoscopic surgery
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Lens extraction
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Lipolysis procedure
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Lipoma excision
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Lithotripsy
|
0.19%
1/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Nasal operation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Open reduction of fracture
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Papilloma excision
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.49%
5/1020 • Number of events 6 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Peripheral nerve neurostimulation
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Phlebectomy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Polypectomy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Pterygium operation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Rhinoplasty
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Splint application
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Suture insertion
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Tenoplasty
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/333 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Tooth extraction
|
1.3%
7/527 • Number of events 9 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.2%
22/1020 • Number of events 23 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.51%
2/389 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.22%
1/453 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Tooth restoration
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Tumour excision
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
0.00%
0/159 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
1/309 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/110 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/130 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/259 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/89 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Vasectomy
|
0.00%
0/368 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.14%
1/711 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/279 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/323 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/602 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/244 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Vitrectomy
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.12%
1/861 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. 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%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Flushing
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Haematoma
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hot flush
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
4.2%
22/527 • Number of events 22 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
52/1020 • Number of events 54 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
14/389 • Number of events 15 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.35%
3/861 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertensive crisis
|
0.57%
3/527 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Lymphorrhoea
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.26%
1/389 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.29%
3/1020 • Number of events 3 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Phlebitis superficial
|
0.19%
1/527 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.10%
1/1020 • Number of events 1 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Varicose vein
|
0.38%
2/527 • Number of events 5 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1020 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
White coat hypertension
|
0.00%
0/527 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.20%
2/1020 • Number of events 2 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/389 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/453 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/861 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/333 • Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60