Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (NCT NCT03449446)
NCT ID: NCT03449446
Last Updated: 2020-12-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
395 participants
Primary outcome timeframe
First dose date up to 48 weeks plus 30 days
Results posted on
2020-12-03
Participant Flow
Participants were enrolled at study sites in United States, Australia, Canada, Hong King and New Zealand. The first participant was screened on 21 Mar 2018. The last study visit occurred on 19 Nov 2019.
950 participants were screened.
Participant milestones
| Measure |
Selonsertib
Participants received selonsertib (SEL) 18 mg tablet + placebo to match firsocostat (FIR) 20 mg tablet + placebo to match cilofexor (CILO) 30 mg tablet orally once daily for 48 weeks.
|
Firsocostat
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Cilofexor
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + FIR
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + CILO
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
FIR + CILO
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
Placebo
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
41
|
80
|
78
|
78
|
39
|
|
Overall Study
COMPLETED
|
3
|
33
|
34
|
71
|
66
|
69
|
38
|
|
Overall Study
NOT COMPLETED
|
36
|
7
|
7
|
9
|
12
|
9
|
1
|
Reasons for withdrawal
| Measure |
Selonsertib
Participants received selonsertib (SEL) 18 mg tablet + placebo to match firsocostat (FIR) 20 mg tablet + placebo to match cilofexor (CILO) 30 mg tablet orally once daily for 48 weeks.
|
Firsocostat
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Cilofexor
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + FIR
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + CILO
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
FIR + CILO
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
Placebo
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Randomized but Never Treated
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Unknown Reason
|
33
|
1
|
1
|
1
|
2
|
2
|
0
|
|
Overall Study
Withdrew Consent
|
1
|
3
|
1
|
4
|
4
|
4
|
1
|
|
Overall Study
Adverse Event
|
1
|
2
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
1
|
3
|
0
|
0
|
|
Overall Study
Investigator's Discretion
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Non Compliance with Study Drug
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
Selonsertib
n=39 Participants
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Firsocostat
n=40 Participants
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Cilofexor
n=40 Participants
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + FIR
n=79 Participants
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + CILO
n=77 Participants
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
FIR + CILO
n=78 Participants
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
Placebo
n=39 Participants
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Total
n=392 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
60 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
57 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
59 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
60 years
STANDARD_DEVIATION 9.0 • n=21 Participants
|
61 years
STANDARD_DEVIATION 8.4 • n=10 Participants
|
61 years
STANDARD_DEVIATION 8.2 • n=115 Participants
|
60 years
STANDARD_DEVIATION 9.0 • n=24 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
253 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
139 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
25 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
68 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
349 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
1 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=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Ethinicity · Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
285 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Ethinicity · Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
105 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Ethinicity · Not Permitted
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Region of Enrollment
New Zealand
|
1 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=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
4 participants
n=21 Participants
|
3 participants
n=10 Participants
|
3 participants
n=115 Participants
|
22 participants
n=24 Participants
|
|
Region of Enrollment
Hong Kong
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=10 Participants
|
1 participants
n=115 Participants
|
10 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
35 participants
n=7 Participants
|
37 participants
n=5 Participants
|
67 participants
n=4 Participants
|
66 participants
n=21 Participants
|
66 participants
n=10 Participants
|
35 participants
n=115 Participants
|
336 participants
n=24 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
7 participants
n=10 Participants
|
0 participants
n=115 Participants
|
23 participants
n=24 Participants
|
|
Diabetes Mellitus Status
Present
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
282 Participants
n=24 Participants
|
|
Diabetes Mellitus Status
Absent
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
110 Participants
n=24 Participants
|
|
Cirrhosis Status
Cirrhotic
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
221 Participants
n=24 Participants
|
|
Cirrhosis Status
Non-Cirrhotic
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
171 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: First dose date up to 48 weeks plus 30 daysPopulation: The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Outcome measures
| Measure |
Selonsertib
n=39 Participants
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Firsocostat
n=40 Participants
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Cilofexor
n=40 Participants
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + FIR
n=79 Participants
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + CILO
n=77 Participants
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
FIR + CILO
n=78 Participants
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
Placebo
n=39 Participants
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
|
84.6 percentage of participants
|
85.0 percentage of participants
|
92.5 percentage of participants
|
88.6 percentage of participants
|
96.1 percentage of participants
|
91.0 percentage of participants
|
79.5 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to 48 weeks plus 30 daysPopulation: Participants in the Safety Analysis Set with available data were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Outcome measures
| Measure |
Selonsertib
n=39 Participants
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Firsocostat
n=40 Participants
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Cilofexor
n=40 Participants
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + FIR
n=79 Participants
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + CILO
n=77 Participants
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
FIR + CILO
n=77 Participants
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
Placebo
n=39 Participants
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
|
94.9 percentage of participants
|
100.0 percentage of participants
|
97.5 percentage of participants
|
98.7 percentage of participants
|
96.1 percentage of participants
|
100.0 percentage of participants
|
94.9 percentage of participants
|
PRIMARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set (included all participants who took at least 1 dose of study drug and were randomized into the study) with available data were analyzed.
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network classification (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. The 95% CI was based on the Clopper-Pearson method.
Outcome measures
| Measure |
Selonsertib
n=7 Participants
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Firsocostat
n=33 Participants
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Cilofexor
n=34 Participants
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + FIR
n=71 Participants
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + CILO
n=68 Participants
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
FIR + CILO
n=67 Participants
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
Placebo
n=38 Participants
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
12.1 percentage of participants
Interval 3.4 to 28.2
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
15.5 percentage of participants
Interval 8.0 to 26.0
|
19.1 percentage of participants
Interval 10.6 to 30.5
|
20.9 percentage of participants
Interval 11.9 to 32.6
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
Adverse Events
Selonsertib
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Firsocostat
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Cilofexor
Serious events: 8 serious events
Other events: 34 other events
Deaths: 0 deaths
SEL + FIR
Serious events: 7 serious events
Other events: 67 other events
Deaths: 0 deaths
SEL + CILO
Serious events: 10 serious events
Other events: 68 other events
Deaths: 1 deaths
FIR + CILO
Serious events: 8 serious events
Other events: 66 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Selonsertib
n=39 participants at risk
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Firsocostat
n=40 participants at risk
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Cilofexor
n=40 participants at risk
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + FIR
n=79 participants at risk
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + CILO
n=77 participants at risk
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
FIR + CILO
n=78 participants at risk
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
Placebo
n=39 participants at risk
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Colonic abscess
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Incision site discharge
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Selonsertib
n=39 participants at risk
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Firsocostat
n=40 participants at risk
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
Cilofexor
n=40 participants at risk
Participants received placebo to match SEL 18 mg + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + FIR
n=79 participants at risk
Participants received SEL 18 mg tablet + FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
SEL + CILO
n=77 participants at risk
Participants received SEL 18 mg tablet + placebo to match FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
FIR + CILO
n=78 participants at risk
Participants received placebo to match SEL 18 mg tablet + FIR 20 mg tablet + CILO 30 mg tablet orally once daily for 48 weeks.
|
Placebo
n=39 participants at risk
Participants received placebo to match SEL 18 mg tablet + placebo to match FIR 20 mg tablet + placebo to match CILO 30 mg tablet orally once daily for 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.3%
5/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.2%
4/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
3/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
7/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
5/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
8/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
15.2%
12/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
26.0%
20/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
24.4%
19/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.8%
5/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.5%
5/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.6%
6/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
7/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.4%
5/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.8%
5/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.0%
4/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.1%
8/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
14.3%
11/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
6/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
5/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
13.9%
11/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
7/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
16.7%
13/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
15.0%
6/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
25.3%
20/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
13.0%
10/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.8%
10/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.7%
10/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
7/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
12.8%
5/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
17.5%
7/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
17.7%
14/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.7%
9/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.3%
8/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Malaise
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
8.9%
7/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.4%
5/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.3%
5/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.1%
8/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.1%
7/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.3%
5/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.2%
4/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.2%
4/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.4%
5/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.0%
4/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
15.0%
6/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.9%
3/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.5%
9/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.8%
5/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.4%
9/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.8%
6/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.4%
5/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
4/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
17.5%
7/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.0%
4/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
17.7%
14/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
15.6%
12/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.3%
8/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
23.1%
9/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
6/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
5/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.4%
9/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.7%
9/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
6/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.4%
9/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.2%
4/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
6/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.8%
5/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
2/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.4%
8/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.3%
5/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.7%
9/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.0%
7/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.2%
4/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.2%
4/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.0%
4/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
8.9%
7/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.2%
4/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.0%
7/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
5/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.4%
8/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.5%
9/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
10.3%
4/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
17.5%
7/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.0%
4/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
13.9%
11/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.8%
6/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
19.2%
15/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
6.5%
5/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.2%
4/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
6/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
7/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.6%
6/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.8%
6/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
9.0%
7/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.8%
3/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.0%
2/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.5%
3/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
11.4%
9/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.8%
6/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
2/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
4/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.5%
1/40 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/79 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
1.3%
1/77 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/78 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • First dose date up to 48 weeks plus 30 days
The Safety Analysis Set included all participants who took 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