Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3 (NCT NCT02466516)
NCT ID: NCT02466516
Last Updated: 2019-06-26
Results Overview
Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Baseline up to last dose plus 30 days (up to Week 28)
Results posted on
2019-06-26
Participant Flow
Participants were enrolled at study sites in United States and Canada. The first participant was screened on 08 June 2015.The last study visit occurred on 11 October 2016.
242 participants were screened.
Participant milestones
| Measure |
SEL 6 mg
Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
|
SEL 18 mg
SEL 18 mg tablet once daily for 24 weeks.
|
SEL 6 mg+SIM 125 mg
SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SEL 18 mg+SIM 125 mg
SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SIM 125 mg
SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
16
|
21
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
SEL 6 mg
Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
|
SEL 18 mg
SEL 18 mg tablet once daily for 24 weeks.
|
SEL 6 mg+SIM 125 mg
SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SEL 18 mg+SIM 125 mg
SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SIM 125 mg
SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrew Consent
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Baseline characteristics by cohort
| Measure |
SEL 6 mg
n=20 Participants
Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
|
SEL 18 mg
n=22 Participants
SEL 18 mg tablet once daily for 24 weeks.
|
SEL 6 mg+SIM 125 mg
n=10 Participants
SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SEL 18 mg+SIM 125 mg
n=10 Participants
SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SIM 125 mg
n=10 Participants
SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
56 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
52 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
51 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
57 years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
54 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
66 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to last dose plus 30 days (up to Week 28)Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Outcome measures
| Measure |
SEL 6 mg
n=20 Participants
Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
|
SEL 18 mg
n=22 Participants
SEL 18 mg tablet once daily for 24 weeks.
|
SEL 6 mg+SIM 125 mg
n=10 Participants
SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SEL 18 mg+SIM 125 mg
n=10 Participants
SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SIM 125 mg
n=10 Participants
SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality
TEAEs
|
17 Participants
|
15 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality
SAEs
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality
Any Grade ≥ 1 Laboratory Abnormality
|
17 Participants
|
21 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to follow up visit (Week 28)Population: Participants in the Safety Analysis Set were analyzed.
Outcome measures
| Measure |
SEL 6 mg
n=20 Participants
Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
|
SEL 18 mg
n=22 Participants
SEL 18 mg tablet once daily for 24 weeks.
|
SEL 6 mg+SIM 125 mg
n=10 Participants
SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SEL 18 mg+SIM 125 mg
n=10 Participants
SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SIM 125 mg
n=10 Participants
SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events
Discontinued Study Drug
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events
Discontinued Study
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
SEL 6 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
SEL 18 mg
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
SEL 6 mg+SIM 125 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SEL 18 mg+SIM 125 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
SIM 125 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SEL 6 mg
n=20 participants at risk
Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
|
SEL 18 mg
n=22 participants at risk
SEL 18 mg tablet once daily for 24 weeks.
|
SEL 6 mg+SIM 125 mg
n=10 participants at risk
SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SEL 18 mg+SIM 125 mg
n=10 participants at risk
SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SIM 125 mg
n=10 participants at risk
SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
SEL 6 mg
n=20 participants at risk
Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
|
SEL 18 mg
n=22 participants at risk
SEL 18 mg tablet once daily for 24 weeks.
|
SEL 6 mg+SIM 125 mg
n=10 participants at risk
SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SEL 18 mg+SIM 125 mg
n=10 participants at risk
SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
SIM 125 mg
n=10 participants at risk
SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
|
|---|---|---|---|---|---|
|
General disorders
Injection site bruising
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
18.2%
4/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
18.2%
4/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
2/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Palatal swelling
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
30.0%
3/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Hernia pain
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
2/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
2/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
30.0%
3/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
30.0%
3/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
2/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood phosphorus decreased
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood pressure increased
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.6%
3/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Amnesia
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
31.8%
7/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
2/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sciatica
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Abnormal dreams
|
10.0%
2/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Euphoric mood
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Schizophrenia
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
2/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
2/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
5.0%
1/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Up to last dose plus 30 days (up to Week 28)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER