Trial Outcomes & Findings for Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin) (NCT NCT04392154)
NCT ID: NCT04392154
Last Updated: 2025-11-05
Results Overview
Percentage of participants discontinued from study treatment due to adverse events is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1153 participants
Primary outcome timeframe
Baseline to Week 100
Results posted on
2025-11-05
Participant Flow
This study consists of 2 parts: * 100-week primary treatment period where participants were assigned to either Lebrikizumab Q4W or Q2W treatment arms. * 32-week open label extension addendum (Lebrikizumab Q4W and Lebrikizumab Q8W)
Participant milestones
| Measure |
Primary Treatment Period: Lebrikizumab Q4W
250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
|
Primary Treatment Period: Lebrikizumab Q2W
250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
|
Open-Label Extension Addendum: Lebrikizumab Q4W
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks.
|
Open-Label Extension Addendum: Lebrikizumab Q8W
250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks.
|
|---|---|---|---|---|
|
Primary Treatment Period (100 Weeks)
STARTED
|
141
|
1012
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Received at Least 1 Dose of Study Drug
|
141
|
1012
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
COMPLETED
|
103
|
675
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
NOT COMPLETED
|
38
|
337
|
0
|
0
|
|
Open-Label Extension Addendum (32 Weeks)
STARTED
|
0
|
0
|
52
|
51
|
|
Open-Label Extension Addendum (32 Weeks)
Received at Least One Doe of Study Drug
|
0
|
0
|
52
|
51
|
|
Open-Label Extension Addendum (32 Weeks)
COMPLETED
|
0
|
0
|
51
|
49
|
|
Open-Label Extension Addendum (32 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Primary Treatment Period: Lebrikizumab Q4W
250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
|
Primary Treatment Period: Lebrikizumab Q2W
250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
|
Open-Label Extension Addendum: Lebrikizumab Q4W
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks.
|
Open-Label Extension Addendum: Lebrikizumab Q8W
250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks.
|
|---|---|---|---|---|
|
Primary Treatment Period (100 Weeks)
Physician Decision
|
1
|
5
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Pregnancy
|
1
|
8
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Protocol deviation
|
1
|
12
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Withdrawal by Subject
|
18
|
138
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Sponsor Decision
|
1
|
14
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Site Closure
|
0
|
4
|
0
|
0
|
|
Open-Label Extension Addendum (32 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Open-Label Extension Addendum (32 Weeks)
Protocol Deviation
|
0
|
0
|
1
|
0
|
|
Open-Label Extension Addendum (32 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Primary Treatment Period (100 Weeks)
Adverse Event
|
3
|
46
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Due to epidemic/pandemic
|
0
|
1
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Lack of Efficacy
|
1
|
47
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Lost to Follow-up
|
11
|
61
|
0
|
0
|
|
Primary Treatment Period (100 Weeks)
Geopolitical conflict
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)
Baseline characteristics by cohort
| Measure |
Primary Treatment Period: Lebrikizumab Q4W
n=141 Participants
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
|
Primary Treatment Period: Lebrikizumab Q2W
n=1012 Participants
250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
|
Total
n=1153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
Taiwan
|
4 Participants
n=15 Participants
|
51 Participants
n=161 Participants
|
55 Participants
n=100 Participants
|
|
Region of Enrollment
South Korea
|
2 Participants
n=15 Participants
|
25 Participants
n=161 Participants
|
27 Participants
n=100 Participants
|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 16.96 • n=15 Participants
|
32.5 years
STANDARD_DEVIATION 17.23 • n=161 Participants
|
32.8 years
STANDARD_DEVIATION 17.21 • n=100 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=15 Participants
|
513 Participants
n=161 Participants
|
595 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=15 Participants
|
499 Participants
n=161 Participants
|
558 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=15 Participants
|
16 Participants
n=161 Participants
|
17 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=15 Participants
|
199 Participants
n=161 Participants
|
220 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=15 Participants
|
9 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=15 Participants
|
138 Participants
n=161 Participants
|
147 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
106 Participants
n=15 Participants
|
610 Participants
n=161 Participants
|
716 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=15 Participants
|
25 Participants
n=161 Participants
|
28 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
15 Participants
n=161 Participants
|
15 Participants
n=100 Participants
|
|
Region of Enrollment
Singapore
|
1 Participants
n=15 Participants
|
7 Participants
n=161 Participants
|
8 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=15 Participants
|
591 Participants
n=161 Participants
|
663 Participants
n=100 Participants
|
|
Region of Enrollment
Ukraine
|
5 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
9 Participants
n=100 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=15 Participants
|
7 Participants
n=161 Participants
|
7 Participants
n=100 Participants
|
|
Region of Enrollment
Canada
|
14 Participants
n=15 Participants
|
80 Participants
n=161 Participants
|
94 Participants
n=100 Participants
|
|
Region of Enrollment
Latvia
|
3 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
8 Participants
n=100 Participants
|
|
Region of Enrollment
Poland
|
23 Participants
n=15 Participants
|
135 Participants
n=161 Participants
|
158 Participants
n=100 Participants
|
|
Region of Enrollment
Mexico
|
2 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
|
Region of Enrollment
Australia
|
3 Participants
n=15 Participants
|
23 Participants
n=161 Participants
|
26 Participants
n=100 Participants
|
|
Region of Enrollment
Bulgaria
|
0 Participants
n=15 Participants
|
10 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
|
Region of Enrollment
Lithuania
|
1 Participants
n=15 Participants
|
12 Participants
n=161 Participants
|
13 Participants
n=100 Participants
|
|
Region of Enrollment
Germany
|
10 Participants
n=15 Participants
|
52 Participants
n=161 Participants
|
62 Participants
n=100 Participants
|
|
Region of Enrollment
Estonia
|
0 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
5 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 100Population: All participants who received at least one dose of study drug.
Percentage of participants discontinued from study treatment due to adverse events is reported.
Outcome measures
| Measure |
Primary Treatment Period: Lebrikizumab Q4W
n=141 Participants
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
|
Primary Treatment Period: Lebrikizumab Q2W
n=1012 Participants
250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
|
|---|---|---|
|
Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events
|
2.1 percentage of participants
|
4.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 100Population: All participants who received at least one dose of study drug.
The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point.
Outcome measures
| Measure |
Primary Treatment Period: Lebrikizumab Q4W
n=141 Participants
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
|
Primary Treatment Period: Lebrikizumab Q2W
n=1012 Participants
250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
|
|---|---|---|
|
Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100
|
80.1 Percentage of participants
|
60.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 100Population: All participants who received at least one dose of study drug.
EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity.
Outcome measures
| Measure |
Primary Treatment Period: Lebrikizumab Q4W
n=141 Participants
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
|
Primary Treatment Period: Lebrikizumab Q2W
n=1012 Participants
250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
|
|---|---|---|
|
Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100
|
90.4 Percentage of participants
|
79.4 Percentage of participants
|
Adverse Events
Primary Treatment Period: Lebrikizumab Q4W
Serious events: 5 serious events
Other events: 89 other events
Deaths: 0 deaths
Primary Treatment Period: Lebrikizumab Q2W
Serious events: 45 serious events
Other events: 638 other events
Deaths: 2 deaths
Open-Label Extension Addendum: Lebrikizumab Q4W
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Open-Label Extension Addendum: Lebrikizumab Q8W
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Treatment Period: Lebrikizumab Q4W
n=141 participants at risk
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
|
Primary Treatment Period: Lebrikizumab Q2W
n=1012 participants at risk
250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
|
Open-Label Extension Addendum: Lebrikizumab Q4W
n=52 participants at risk
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks.
|
Open-Label Extension Addendum: Lebrikizumab Q8W
n=51 participants at risk
250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Sudden visual loss
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Death
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Food allergy
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Accident
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Stevens-johnson syndrome
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Primary Treatment Period: Lebrikizumab Q4W
n=141 participants at risk
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
|
Primary Treatment Period: Lebrikizumab Q2W
n=1012 participants at risk
250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
|
Open-Label Extension Addendum: Lebrikizumab Q4W
n=52 participants at risk
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks.
|
Open-Label Extension Addendum: Lebrikizumab Q8W
n=51 participants at risk
250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks.
|
|---|---|---|---|---|
|
Eye disorders
Eyelid oedema
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Glaucoma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Keratitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Keratoconus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Myopia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Periorbital dermatitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Scleritis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vernal keratoconjunctivitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.69%
7/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Thyroid cyst
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Allergic keratitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Astigmatism
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Blepharitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Blepharitis allergic
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Chalazion
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctival irritation
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctivitis allergic
|
2.8%
4/141 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.9%
29/1012 • Number of events 39 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Corneal neovascularisation
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Eczema eyelids
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Eye irritation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Eye disorders
Eye swelling
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Swelling face
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Vaccination site pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.79%
8/1012 • Number of events 16 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Vaccination site reaction
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.3%
13/1012 • Number of events 15 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.89%
9/1012 • Number of events 10 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site rash
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
0.71%
1/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.2%
12/1012 • Number of events 32 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site swelling
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.69%
7/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Dust allergy
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Food allergy
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.89%
9/1012 • Number of events 10 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Abscess of eyelid
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Enterobiasis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Erythrasma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Eye infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.71%
1/141 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.1%
11/1012 • Number of events 12 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Alveolar osteitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Ascariasis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacterial vaginosis
|
1.4%
2/141 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Eczema infected
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.3%
13/1012 • Number of events 16 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gingivitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Impetigo
|
1.4%
2/141 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.79%
8/1012 • Number of events 10 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Infected bite
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Laryngitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Norovirus infection
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.59%
6/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Toxocariasis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood potassium increased
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Heart rate increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Helicobacter test positive
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Liver function test increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte morphology abnormal
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
White blood cells urine positive
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.69%
7/1012 • Number of events 8 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
2.8%
4/141 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.5%
25/1012 • Number of events 33 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Occipital neuralgia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Piriformis syndrome
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Protein urine present
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mania
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.69%
7/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.79%
8/1012 • Number of events 8 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.5%
15/1012 • Number of events 15 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Vith nerve paralysis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Polycystic ovarian syndrome
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.59%
6/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.99%
10/1012 • Number of events 12 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.89%
9/1012 • Number of events 10 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal vascular disorder
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Malpositioned teeth
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.89%
9/1012 • Number of events 9 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stress ulcer
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site haematoma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Metabolic dysfunction-associated liver disease
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Metabolic dysfunction-associated steatohepatitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Allergy to venom
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Blastocystis infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Body tinea
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.1%
11/1012 • Number of events 11 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Chronic sinusitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
2.1%
3/141 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
3.9%
39/1012 • Number of events 45 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis bacterial
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis viral
|
0.71%
1/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Coronavirus infection
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
18.4%
26/141 • Number of events 29 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
15.7%
159/1012 • Number of events 172 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Genital infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Helicobacter infection
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
1.4%
2/141 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.99%
10/1012 • Number of events 15 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.1%
11/1012 • Number of events 15 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.2%
12/1012 • Number of events 12 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Infusion site cellulitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Malassezia infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nail infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
9.2%
13/141 • Number of events 14 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
11.4%
115/1012 • Number of events 165 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
1.4%
2/141 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
3.0%
30/1012 • Number of events 46 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Orchitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
2.8%
4/141 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.5%
15/1012 • Number of events 15 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin candida
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
7/141 • Number of events 11 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
4.8%
49/1012 • Number of events 63 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
3/141 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
3.0%
30/1012 • Number of events 35 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Abdominal wall wound
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Eyelid abrasion
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foreign body in ear
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.69%
7/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Superficial injury of eye
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 10 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.7%
17/1012 • Number of events 18 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.69%
7/1012 • Number of events 8 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Bilirubin urine
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Bilirubin urine present
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood bicarbonate decreased
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood immunoglobulin e increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood iron decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood testosterone decreased
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Cardiac murmur
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Double stranded dna antibody positive
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.59%
6/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.69%
7/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Glucose urine present
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin urine present
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count increased
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Red blood cell morphology abnormal
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Sars-cov-2 test positive
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Treponema test positive
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Tri-iodothyronine free increased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Urine ketone body present
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Histamine intolerance
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Periarthritis calcarea
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.5%
15/1012 • Number of events 19 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.4%
14/1012 • Number of events 17 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.69%
7/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dementia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tension headache
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Morning sickness
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine hypertonus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.1%
11/1012 • Number of events 11 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Autism spectrum disorder
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Bipolar i disorder
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.99%
10/1012 • Number of events 10 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.69%
7/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Sleep disorder due to general medical condition, insomnia type
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 26 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.59%
6/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.2%
12/1012 • Number of events 13 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.59%
6/1012 • Number of events 6 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 7 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.7%
17/1012 • Number of events 19 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne varioliformis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.40%
4/1012 • Number of events 8 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Androgenetic alopecia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Chronic cutaneous lupus erythematosus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cutaneous calcification
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 4 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
6.4%
9/141 • Number of events 12 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
6.9%
70/1012 • Number of events 102 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.4%
2/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.49%
5/1012 • Number of events 5 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.71%
1/141 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Lichen striatus
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Mechanical urticaria
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Parapsoriasis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.30%
3/1012 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.20%
2/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.59%
6/1012 • Number of events 9 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.71%
1/141 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.71%
1/141 • Number of events 3 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.1%
11/1012 • Number of events 11 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria contact
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 2 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.10%
1/1012 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Accessory navicular syndrome
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/52 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
2.0%
1/51 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/141 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/1012 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
0.00%
0/51 • Primary Treatment Period: Up to 110 Weeks; Open-Label Extension Addendum: up to 42 weeks
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60