Trial Outcomes & Findings for Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant (NCT NCT02010255)
NCT ID: NCT02010255
Last Updated: 2018-11-19
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
334 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-19
Participant Flow
Participants were enrolled at study sites in Europe, Canada, Australia, and New Zealand. The first participant was screened on 14 January 2014. The last study visit occurred on 27 August 2015.
* Cohort A: decompensated cirrhosis \[advanced liver disease\], no prior liver transplant; * Cohort B: post-liver transplant, with or without cirrhosis; * Group assignment within cohorts was based on severity of liver impairment at screening \[or presence of disease for FCH groups\]; * Randomization was 1:1 within groups to 12 or 24 weeks of treatment.
Participant milestones
| Measure |
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease.
|
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis.
|
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
|
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
25
|
26
|
52
|
49
|
34
|
33
|
22
|
23
|
3
|
5
|
3
|
3
|
|
Overall Study
COMPLETED
|
22
|
26
|
18
|
20
|
48
|
49
|
33
|
32
|
21
|
23
|
1
|
4
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
7
|
6
|
4
|
0
|
1
|
1
|
1
|
0
|
2
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease.
|
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis.
|
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
|
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
4
|
4
|
2
|
0
|
1
|
1
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
4
|
1
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrew Consent
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Randomized but Not Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
Baseline characteristics by cohort
| Measure |
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
n=28 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
n=28 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
n=52 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
|
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
n=49 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
|
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
n=34 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
n=33 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
n=22 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
56 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
58 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
54 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
58 years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
59 years
STANDARD_DEVIATION 6.9 • n=10 Participants
|
57 years
STANDARD_DEVIATION 7.2 • n=115 Participants
|
62 years
STANDARD_DEVIATION 7.5 • n=6 Participants
|
58 years
STANDARD_DEVIATION 8.0 • n=6 Participants
|
60 years
STANDARD_DEVIATION 10.2 • n=64 Participants
|
62 years
STANDARD_DEVIATION 4.6 • n=17 Participants
|
62 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
58 years
STANDARD_DEVIATION 2.6 • n=22 Participants
|
56 years
STANDARD_DEVIATION 2.8 • n=8 Participants
|
58 years
STANDARD_DEVIATION 8.4 • n=16 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
8 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
82 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
26 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
15 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
251 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
57 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
26 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
19 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
2 Participants
n=8 Participants
|
276 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
1 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
5 participants
n=16 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=5 Participants
|
28 participants
n=7 Participants
|
23 participants
n=5 Participants
|
25 participants
n=4 Participants
|
50 participants
n=21 Participants
|
47 participants
n=10 Participants
|
33 participants
n=115 Participants
|
30 participants
n=6 Participants
|
21 participants
n=6 Participants
|
21 participants
n=64 Participants
|
3 participants
n=17 Participants
|
5 participants
n=21 Participants
|
2 participants
n=22 Participants
|
1 participants
n=8 Participants
|
314 participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
3 participants
n=6 Participants
|
0 participants
n=6 Participants
|
1 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
1 participants
n=22 Participants
|
1 participants
n=8 Participants
|
7 participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
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
|
1 participants
n=115 Participants
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
2 participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
1 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
5 participants
n=16 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
2 participants
n=6 Participants
|
2 participants
n=6 Participants
|
1 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
2 participants
n=22 Participants
|
0 participants
n=8 Participants
|
16 participants
n=16 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
1 participants
n=4 Participants
|
8 participants
n=21 Participants
|
6 participants
n=10 Participants
|
4 participants
n=115 Participants
|
5 participants
n=6 Participants
|
4 participants
n=6 Participants
|
5 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
1 participants
n=8 Participants
|
49 participants
n=16 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
8 participants
n=21 Participants
|
2 participants
n=10 Participants
|
2 participants
n=115 Participants
|
3 participants
n=6 Participants
|
1 participants
n=6 Participants
|
2 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
23 participants
n=16 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
4 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
1 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
8 participants
n=16 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
1 participants
n=115 Participants
|
1 participants
n=6 Participants
|
0 participants
n=6 Participants
|
2 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
16 participants
n=16 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=10 Participants
|
3 participants
n=115 Participants
|
1 participants
n=6 Participants
|
3 participants
n=6 Participants
|
3 participants
n=64 Participants
|
1 participants
n=17 Participants
|
2 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
23 participants
n=16 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
8 participants
n=21 Participants
|
9 participants
n=10 Participants
|
4 participants
n=115 Participants
|
5 participants
n=6 Participants
|
0 participants
n=6 Participants
|
0 participants
n=64 Participants
|
1 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
36 participants
n=16 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
3 participants
n=115 Participants
|
3 participants
n=6 Participants
|
2 participants
n=6 Participants
|
2 participants
n=64 Participants
|
0 participants
n=17 Participants
|
1 participants
n=21 Participants
|
0 participants
n=22 Participants
|
1 participants
n=8 Participants
|
27 participants
n=16 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
5 participants
n=10 Participants
|
6 participants
n=115 Participants
|
3 participants
n=6 Participants
|
3 participants
n=6 Participants
|
3 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
1 participants
n=22 Participants
|
0 participants
n=8 Participants
|
32 participants
n=16 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
3 participants
n=10 Participants
|
4 participants
n=115 Participants
|
2 participants
n=6 Participants
|
2 participants
n=6 Participants
|
0 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
23 participants
n=16 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
5 participants
n=10 Participants
|
0 participants
n=115 Participants
|
3 participants
n=6 Participants
|
1 participants
n=6 Participants
|
1 participants
n=64 Participants
|
0 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
28 participants
n=16 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
4 participants
n=21 Participants
|
8 participants
n=10 Participants
|
5 participants
n=115 Participants
|
5 participants
n=6 Participants
|
3 participants
n=6 Participants
|
4 participants
n=64 Participants
|
1 participants
n=17 Participants
|
2 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
52 participants
n=16 Participants
|
|
Hepatitis C Virus (HCV) RNA
|
6.0 log 10 IU/mL
STANDARD_DEVIATION 0.49 • n=5 Participants
|
5.9 log 10 IU/mL
STANDARD_DEVIATION 0.56 • n=7 Participants
|
5.6 log 10 IU/mL
STANDARD_DEVIATION 0.58 • n=5 Participants
|
5.7 log 10 IU/mL
STANDARD_DEVIATION 0.44 • n=4 Participants
|
6.4 log 10 IU/mL
STANDARD_DEVIATION 0.72 • n=21 Participants
|
6.5 log 10 IU/mL
STANDARD_DEVIATION 0.44 • n=10 Participants
|
6.3 log 10 IU/mL
STANDARD_DEVIATION 0.58 • n=115 Participants
|
6.5 log 10 IU/mL
STANDARD_DEVIATION 0.55 • n=6 Participants
|
6.1 log 10 IU/mL
STANDARD_DEVIATION 0.78 • n=6 Participants
|
6.2 log 10 IU/mL
STANDARD_DEVIATION 0.85 • n=64 Participants
|
6.0 log 10 IU/mL
STANDARD_DEVIATION 0.49 • n=17 Participants
|
6.5 log 10 IU/mL
STANDARD_DEVIATION 0.50 • n=21 Participants
|
7.3 log 10 IU/mL
STANDARD_DEVIATION 0.72 • n=22 Participants
|
6.0 log 10 IU/mL
STANDARD_DEVIATION 0.41 • n=8 Participants
|
6.2 log 10 IU/mL
STANDARD_DEVIATION 0.66 • n=16 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
17 participants
n=4 Participants
|
12 participants
n=21 Participants
|
5 participants
n=10 Participants
|
9 participants
n=115 Participants
|
5 participants
n=6 Participants
|
5 participants
n=6 Participants
|
9 participants
n=64 Participants
|
2 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
1 participants
n=8 Participants
|
106 participants
n=16 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
40 participants
n=21 Participants
|
44 participants
n=10 Participants
|
25 participants
n=115 Participants
|
28 participants
n=6 Participants
|
17 participants
n=6 Participants
|
14 participants
n=64 Participants
|
1 participants
n=17 Participants
|
5 participants
n=21 Participants
|
3 participants
n=22 Participants
|
1 participants
n=8 Participants
|
227 participants
n=16 Participants
|
|
HCV Genotype
Genotype 1a
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
12 participants
n=4 Participants
|
27 participants
n=21 Participants
|
29 participants
n=10 Participants
|
14 participants
n=115 Participants
|
13 participants
n=6 Participants
|
11 participants
n=6 Participants
|
13 participants
n=64 Participants
|
1 participants
n=17 Participants
|
1 participants
n=21 Participants
|
2 participants
n=22 Participants
|
2 participants
n=8 Participants
|
163 participants
n=16 Participants
|
|
HCV Genotype
Genotype 1b
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
18 participants
n=21 Participants
|
15 participants
n=10 Participants
|
16 participants
n=115 Participants
|
15 participants
n=6 Participants
|
9 participants
n=6 Participants
|
7 participants
n=64 Participants
|
1 participants
n=17 Participants
|
4 participants
n=21 Participants
|
1 participants
n=22 Participants
|
0 participants
n=8 Participants
|
133 participants
n=16 Participants
|
|
HCV Genotype
Genotype 4
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
5 participants
n=10 Participants
|
4 participants
n=115 Participants
|
5 participants
n=6 Participants
|
2 participants
n=6 Participants
|
3 participants
n=64 Participants
|
1 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
37 participants
n=16 Participants
|
|
IL28b Status
CC
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
10 participants
n=10 Participants
|
3 participants
n=115 Participants
|
7 participants
n=6 Participants
|
3 participants
n=6 Participants
|
5 participants
n=64 Participants
|
0 participants
n=17 Participants
|
3 participants
n=21 Participants
|
0 participants
n=22 Participants
|
1 participants
n=8 Participants
|
67 participants
n=16 Participants
|
|
IL28b Status
CT
|
18 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
15 participants
n=4 Participants
|
31 participants
n=21 Participants
|
25 participants
n=10 Participants
|
23 participants
n=115 Participants
|
21 participants
n=6 Participants
|
12 participants
n=6 Participants
|
11 participants
n=64 Participants
|
2 participants
n=17 Participants
|
2 participants
n=21 Participants
|
3 participants
n=22 Participants
|
1 participants
n=8 Participants
|
184 participants
n=16 Participants
|
|
IL28b Status
TT
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
7 participants
n=4 Participants
|
12 participants
n=21 Participants
|
14 participants
n=10 Participants
|
8 participants
n=115 Participants
|
5 participants
n=6 Participants
|
7 participants
n=6 Participants
|
7 participants
n=64 Participants
|
1 participants
n=17 Participants
|
0 participants
n=21 Participants
|
0 participants
n=22 Participants
|
0 participants
n=8 Participants
|
82 participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=21 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
100.0 percentage of participants
|
84.6 percentage of participants
|
96.0 percentage of participants
|
81.0 percentage of participants
|
76.0 percentage of participants
|
94.2 percentage of participants
|
100.0 percentage of participants
|
97.1 percentage of participants
|
97.0 percentage of participants
|
95.5 percentage of participants
|
33.3 percentage of participants
|
80.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants who were randomized and received at least one dose of study drug
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=28 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=28 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=25 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=26 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Discontinued Any Study Drug
|
17.4 percentage of participants
|
3.6 percentage of participants
|
7.1 percentage of participants
|
16.0 percentage of participants
|
23.1 percentage of participants
|
5.8 percentage of participants
|
6.1 percentage of participants
|
0.0 percentage of participants
|
15.2 percentage of participants
|
18.2 percentage of participants
|
33.3 percentage of participants
|
20.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Discontinued LDV/SOF
|
0.0 percentage of participants
|
3.6 percentage of participants
|
3.6 percentage of participants
|
0.0 percentage of participants
|
7.7 percentage of participants
|
1.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
20.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 2Population: Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.
SVR2 was defined as HCV RNA \< LLOQ at 2 weeks after stopping study treatment.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=26 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=23 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
|
100.0 percentage of participants
|
96.2 percentage of participants
|
100.0 percentage of participants
|
91.3 percentage of participants
|
80.0 percentage of participants
|
98.1 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
97.0 percentage of participants
|
95.5 percentage of participants
|
100.0 percentage of participants
|
80.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=26 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
|
100.0 Percentage of participants
|
88.5 Percentage of participants
|
100.0 Percentage of participants
|
90.9 Percentage of participants
|
80.0 Percentage of participants
|
94.2 Percentage of participants
|
100.0 Percentage of participants
|
97.1 Percentage of participants
|
97.0 Percentage of participants
|
95.5 Percentage of participants
|
100.0 Percentage of participants
|
80.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 8Population: Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.
SVR8 was defined as HCV RNA \< LLOQ at 8 weeks after stopping study treatment.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=26 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
|
100.0 Percentage of participants
|
84.6 Percentage of participants
|
96.2 Percentage of participants
|
81.8 Percentage of participants
|
80.0 Percentage of participants
|
94.2 Percentage of participants
|
100.0 Percentage of participants
|
97.1 Percentage of participants
|
97.0 Percentage of participants
|
95.5 Percentage of participants
|
33.3 Percentage of participants
|
80.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Full Analysis Set. Participants in Cohort A and 1 participant in Cohort B who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=22 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=25 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=20 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
|
100.0 Percentage of participants
|
84.0 Percentage of participants
|
96.0 Percentage of participants
|
80.0 Percentage of participants
|
76.0 Percentage of participants
|
94.2 Percentage of participants
|
100.0 Percentage of participants
|
97.1 Percentage of participants
|
97.0 Percentage of participants
|
95.5 Percentage of participants
|
33.3 Percentage of participants
|
80.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA \<LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ on 2 consecutive measurements while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=21 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
0.0 Percentage of participants
|
15.4 Percentage of participants
|
4.0 Percentage of participants
|
9.5 Percentage of participants
|
4.0 Percentage of participants
|
1.9 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 12Population: Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was \< LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.
pTVR was defined as HCV RNA \< LLOQ at Week 12 after transplant.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=10 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
|
—
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=25 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=26 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 1
|
8.7 Percentage of participants
|
3.8 Percentage of participants
|
3.7 Percentage of participants
|
12.0 Percentage of participants
|
3.8 Percentage of participants
|
9.6 Percentage of participants
|
6.1 Percentage of participants
|
5.9 Percentage of participants
|
3.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2Population: Full Analysis Set
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=25 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=26 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 2
|
30.4 Percentage of participants
|
26.9 Percentage of participants
|
37.0 Percentage of participants
|
40.0 Percentage of participants
|
38.5 Percentage of participants
|
48.1 Percentage of participants
|
44.9 Percentage of participants
|
26.5 Percentage of participants
|
21.2 Percentage of participants
|
31.8 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=25 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=26 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 4
|
82.6 Percentage of participants
|
76.9 Percentage of participants
|
81.5 Percentage of participants
|
80.0 Percentage of participants
|
84.6 Percentage of participants
|
84.6 Percentage of participants
|
91.8 Percentage of participants
|
67.6 Percentage of participants
|
81.8 Percentage of participants
|
72.7 Percentage of participants
|
100 Percentage of participants
|
25 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=24 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 6
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
91.7 Percentage of participants
|
100.0 Percentage of participants
|
98.1 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
97.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=24 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=32 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 8
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
96.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
96.9 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=24 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=24 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=51 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=32 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 12
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
95.5 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=22 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=49 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=32 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=23 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=4 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=2 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 16
|
—
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=21 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=49 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=32 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=23 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=4 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=2 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 20
|
—
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=25 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=21 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=49 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=32 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=23 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=4 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=2 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 24
|
—
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 1Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=24 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HCV RNA Levels and Change From Baseline at Week 1
Week 1
|
2.75 log10 IU/mL
Standard Deviation 0.888
|
2.44 log10 IU/mL
Standard Deviation 0.665
|
2.47 log10 IU/mL
Standard Deviation 0.696
|
2.32 log10 IU/mL
Standard Deviation 0.868
|
2.50 log10 IU/mL
Standard Deviation 0.645
|
2.38 log10 IU/mL
Standard Deviation 0.716
|
2.38 log10 IU/mL
Standard Deviation 0.653
|
2.64 log10 IU/mL
Standard Deviation 0.784
|
2.81 log10 IU/mL
Standard Deviation 0.729
|
2.63 log10 IU/mL
Standard Deviation 0.780
|
2.97 log10 IU/mL
Standard Deviation 0.229
|
3.73 log10 IU/mL
Standard Deviation 0.434
|
2.91 log10 IU/mL
Standard Deviation 0.825
|
2.28 log10 IU/mL
Standard Deviation 0.620
|
|
HCV RNA Levels and Change From Baseline at Week 1
Change at Week 1
|
-3.44 log10 IU/mL
Standard Deviation 0.789
|
-3.60 log10 IU/mL
Standard Deviation 0.535
|
-3.39 log10 IU/mL
Standard Deviation 0.634
|
-3.28 log10 IU/mL
Standard Deviation 0.735
|
-3.20 log10 IU/mL
Standard Deviation 0.610
|
-3.98 log10 IU/mL
Standard Deviation 0.611
|
-4.12 log10 IU/mL
Standard Deviation 0.538
|
-3.70 log10 IU/mL
Standard Deviation 0.489
|
-3.65 log10 IU/mL
Standard Deviation 0.562
|
-3.50 log10 IU/mL
Standard Deviation 0.666
|
-3.06 log10 IU/mL
Standard Deviation 0.645
|
-2.74 log10 IU/mL
Standard Deviation 0.446
|
-4.40 log10 IU/mL
Standard Deviation 0.503
|
-3.76 log10 IU/mL
Standard Deviation 0.213
|
SECONDARY outcome
Timeframe: Baseline; Week 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=25 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=26 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=48 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=33 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=33 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HCV RNA Levels and Change From Baseline at Week 2
Change at Week 2
|
-4.20 log10 IU/mL
Standard Deviation 0.764
|
-4.29 log10 IU/mL
Standard Deviation 0.534
|
-4.17 log10 IU/mL
Standard Deviation 0.538
|
-3.92 log10 IU/mL
Standard Deviation 0.610
|
-3.99 log10 IU/mL
Standard Deviation 0.566
|
-4.74 log10 IU/mL
Standard Deviation 0.733
|
-5.00 log10 IU/mL
Standard Deviation 0.522
|
-4.42 log10 IU/mL
Standard Deviation 0.729
|
-4.48 log10 IU/mL
Standard Deviation 0.583
|
-4.26 log10 IU/mL
Standard Deviation 0.708
|
-3.95 log10 IU/mL
Standard Deviation 0.796
|
-3.66 log10 IU/mL
Standard Deviation 0.601
|
-5.46 log10 IU/mL
Standard Deviation 0.756
|
-4.38 log10 IU/mL
Standard Deviation 0.285
|
|
HCV RNA Levels and Change From Baseline at Week 2
Week 2
|
2.00 log10 IU/mL
Standard Deviation 0.718
|
1.76 log10 IU/mL
Standard Deviation 0.668
|
1.70 log10 IU/mL
Standard Deviation 0.579
|
1.71 log10 IU/mL
Standard Deviation 0.625
|
1.72 log10 IU/mL
Standard Deviation 0.573
|
1.62 log10 IU/mL
Standard Deviation 0.604
|
1.49 log10 IU/mL
Standard Deviation 0.477
|
1.92 log10 IU/mL
Standard Deviation 0.839
|
1.97 log10 IU/mL
Standard Deviation 0.607
|
1.86 log10 IU/mL
Standard Deviation 0.607
|
2.08 log10 IU/mL
Standard Deviation 0.378
|
2.81 log10 IU/mL
Standard Deviation 0.709
|
1.85 log10 IU/mL
Standard Deviation 0.731
|
1.65 log10 IU/mL
Standard Deviation 0.122
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=24 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=32 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HCV RNA Levels and Change From Baseline at Week 4
Week 4
|
1.32 log10 IU/mL
Standard Deviation 0.408
|
1.26 log10 IU/mL
Standard Deviation 0.257
|
1.20 log10 IU/mL
Standard Deviation 0.148
|
1.23 log10 IU/mL
Standard Deviation 0.205
|
1.18 log10 IU/mL
Standard Deviation 0.147
|
1.23 log10 IU/mL
Standard Deviation 0.247
|
1.18 log10 IU/mL
Standard Deviation 0.129
|
1.29 log10 IU/mL
Standard Deviation 0.301
|
1.21 log10 IU/mL
Standard Deviation 0.154
|
1.25 log10 IU/mL
Standard Deviation 0.199
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.56 log10 IU/mL
Standard Deviation 0.585
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA Levels and Change From Baseline at Week 4
Change at Week 4
|
-4.87 log10 IU/mL
Standard Deviation 0.816
|
-4.78 log10 IU/mL
Standard Deviation 0.430
|
-4.66 log10 IU/mL
Standard Deviation 0.518
|
-4.45 log10 IU/mL
Standard Deviation 0.521
|
-4.52 log10 IU/mL
Standard Deviation 0.492
|
-5.13 log10 IU/mL
Standard Deviation 0.721
|
-5.32 log10 IU/mL
Standard Deviation 0.453
|
-5.05 log10 IU/mL
Standard Deviation 0.526
|
-5.25 log10 IU/mL
Standard Deviation 0.518
|
-4.88 log10 IU/mL
Standard Deviation 0.762
|
-4.89 log10 IU/mL
Standard Deviation 0.490
|
-4.91 log10 IU/mL
Standard Deviation 0.240
|
-6.16 log10 IU/mL
Standard Deviation 0.725
|
-4.89 log10 IU/mL
Standard Deviation 0.407
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=23 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=25 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=51 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=32 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HCV RNA Levels and Change From Baseline at Week 6
Week 6
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.17 log10 IU/mL
Standard Deviation 0.102
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA Levels and Change From Baseline at Week 6
Change at Week 6
|
-5.05 log10 IU/mL
Standard Deviation 0.851
|
-4.90 log10 IU/mL
Standard Deviation 0.487
|
-4.72 log10 IU/mL
Standard Deviation 0.535
|
-4.51 log10 IU/mL
Standard Deviation 0.527
|
-4.56 log10 IU/mL
Standard Deviation 0.445
|
-5.21 log10 IU/mL
Standard Deviation 0.728
|
-5.35 log10 IU/mL
Standard Deviation 0.436
|
-5.19 log10 IU/mL
Standard Deviation 0.577
|
-5.31 log10 IU/mL
Standard Deviation 0.557
|
-4.98 log10 IU/mL
Standard Deviation 0.779
|
-4.89 log10 IU/mL
Standard Deviation 0.490
|
-5.33 log10 IU/mL
Standard Deviation 0.574
|
-6.16 log10 IU/mL
Standard Deviation 0.725
|
-4.89 log10 IU/mL
Standard Deviation 0.407
|
SECONDARY outcome
Timeframe: Baseline; Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=24 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=24 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=52 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=31 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=22 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HCV RNA Levels and Change From Baseline at Week 8
Week 8
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA Levels and Change From Baseline at Week 8
Change at Week 8
|
-5.05 log10 IU/mL
Standard Deviation 0.851
|
-4.90 log10 IU/mL
Standard Deviation 0.487
|
-4.72 log10 IU/mL
Standard Deviation 0.535
|
-4.53 log10 IU/mL
Standard Deviation 0.534
|
-4.60 log10 IU/mL
Standard Deviation 0.393
|
-5.21 log10 IU/mL
Standard Deviation 0.722
|
-5.35 log10 IU/mL
Standard Deviation 0.436
|
-5.19 log10 IU/mL
Standard Deviation 0.577
|
-5.31 log10 IU/mL
Standard Deviation 0.565
|
-4.98 log10 IU/mL
Standard Deviation 0.779
|
-4.89 log10 IU/mL
Standard Deviation 0.490
|
-5.33 log10 IU/mL
Standard Deviation 0.574
|
-6.16 log10 IU/mL
Standard Deviation 0.725
|
-4.89 log10 IU/mL
Standard Deviation 0.407
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=23 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=26 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=27 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=24 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=24 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=51 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=49 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=34 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=32 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=21 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HCV RNA Levels and Change From Baseline at Week 12
Week 12
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA Levels and Change From Baseline at Week 12
Change at Week 12
|
-5.05 log10 IU/mL
Standard Deviation 0.851
|
-4.90 log10 IU/mL
Standard Deviation 0.487
|
-4.72 log10 IU/mL
Standard Deviation 0.535
|
-4.53 log10 IU/mL
Standard Deviation 0.534
|
-4.60 log10 IU/mL
Standard Deviation 0.393
|
-5.21 log10 IU/mL
Standard Deviation 0.729
|
-5.35 log10 IU/mL
Standard Deviation 0.436
|
-5.19 log10 IU/mL
Standard Deviation 0.577
|
-5.30 log10 IU/mL
Standard Deviation 0.556
|
-4.98 log10 IU/mL
Standard Deviation 0.798
|
-4.89 log10 IU/mL
Standard Deviation 0.490
|
-5.33 log10 IU/mL
Standard Deviation 0.574
|
-6.16 log10 IU/mL
Standard Deviation 0.725
|
-4.89 log10 IU/mL
Standard Deviation 0.407
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 4Population: Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=24 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=22 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=21 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=20 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=32 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=32 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=21 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=23 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=2 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Decrease
|
75.0 percentage of participants
|
70.8 percentage of participants
|
77.3 percentage of participants
|
81.0 percentage of participants
|
70.0 percentage of participants
|
28.1 percentage of participants
|
62.5 percentage of participants
|
66.7 percentage of participants
|
65.2 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
No Change
|
0.0 percentage of participants
|
12.5 percentage of participants
|
9.1 percentage of participants
|
14.3 percentage of participants
|
5.0 percentage of participants
|
31.3 percentage of participants
|
18.8 percentage of participants
|
14.3 percentage of participants
|
17.4 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Increase
|
25.0 percentage of participants
|
16.7 percentage of participants
|
13.6 percentage of participants
|
4.8 percentage of participants
|
25.0 percentage of participants
|
40.6 percentage of participants
|
18.8 percentage of participants
|
19.0 percentage of participants
|
17.4 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 4Population: Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.
Outcome measures
| Measure |
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A: Baseline CPT Class B (12 wk)
n=28 Participants
Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class B (24 wk)
n=23 Participants
Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (12 wk)
n=17 Participants
Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort A: Baseline CPT Class C (24 wk)
n=19 Participants
Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (12 wk)
n=35 Participants
Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class A (24 wk)
n=34 Participants
Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (12 wk)
n=18 Participants
Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class B (24 wk)
n=20 Participants
Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B: Baseline CPT Class C (12 wk)
n=2 Participants
Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
Decrease
|
80.0 percentage of participants
|
64.3 percentage of participants
|
87.0 percentage of participants
|
82.4 percentage of participants
|
73.7 percentage of participants
|
28.6 percentage of participants
|
23.5 percentage of participants
|
61.1 percentage of participants
|
85.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
No Change
|
20.0 percentage of participants
|
28.6 percentage of participants
|
13.0 percentage of participants
|
11.8 percentage of participants
|
26.3 percentage of participants
|
68.6 percentage of participants
|
61.8 percentage of participants
|
33.3 percentage of participants
|
10.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
Increase
|
0.0 percentage of participants
|
7.1 percentage of participants
|
0.0 percentage of participants
|
5.9 percentage of participants
|
0.0 percentage of participants
|
2.9 percentage of participants
|
14.7 percentage of participants
|
5.6 percentage of participants
|
5.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
Serious events: 13 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
Serious events: 10 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
Serious events: 9 serious events
Other events: 49 other events
Deaths: 0 deaths
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
Serious events: 5 serious events
Other events: 48 other events
Deaths: 0 deaths
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort B, Group 7 (12 wk): FCH
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B, Group 7 (24 wk): FCH
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
n=28 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease.
|
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
n=28 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
n=25 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
n=26 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
n=52 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis.
|
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
n=49 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
|
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
n=34 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
n=33 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
n=22 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
n=23 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Cardiac septal hypertrophy
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Congenital, familial and genetic disorders
Left ventricle outflow tract obstruction
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Colitis
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haematemesis
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Chills
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Device dislocation
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Malaise
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Immune system disorders
Liver transplant rejection
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Anal abscess
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Empyema
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Erysipelas
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Peritoneal tuberculosis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Urosepsis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
Other adverse events
| Measure |
Cohort A, Group 1 (12 wk): CPT Class B (7-9)
n=28 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease.
|
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
n=28 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
n=25 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
n=26 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
n=52 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis.
|
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
n=49 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
|
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
n=34 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
n=33 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
|
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
n=22 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
n=23 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
|
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
n=3 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
n=5 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
|
Cohort B, Group 7 (12 wk): FCH
n=3 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
|
Cohort B, Group 7 (24 wk): FCH
n=2 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.0%
3/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.2%
5/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.9%
2/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
17.9%
5/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
21.4%
6/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.0%
3/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.5%
3/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
23.1%
12/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
22.4%
11/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
14.7%
5/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
11/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
40.0%
2/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.7%
3/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
5/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
30.8%
8/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
40.4%
21/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
55.1%
27/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
29.4%
10/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
45.5%
15/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
27.3%
6/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
52.2%
12/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.7%
3/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Eyelid cyst
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Ocular icterus
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Pterygium
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Eye disorders
Vision blurred
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.7%
3/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.6%
5/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.2%
4/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.1%
4/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.9%
2/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.1%
2/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.7%
3/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.0%
3/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
4/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.2%
5/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.8%
3/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.1%
4/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.0%
3/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.2%
4/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.8%
3/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.7%
3/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.1%
2/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
21.4%
6/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
14.3%
4/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
16.0%
4/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
19.2%
5/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
25.0%
13/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.2%
6/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
14.7%
5/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
30.3%
10/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
27.3%
6/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
13.0%
3/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
24.0%
6/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.5%
3/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.6%
5/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.8%
4/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.1%
4/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
13.6%
3/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
17.4%
4/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Asthenia
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.0%
3/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
15.4%
4/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
4/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.2%
4/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
14.7%
5/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
21.2%
7/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
17.4%
4/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Chest pain
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.1%
2/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.9%
2/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Fatigue
|
35.7%
10/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
32.1%
9/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
5/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
30.8%
8/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
42.3%
22/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
40.8%
20/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
23.5%
8/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
11/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
31.8%
7/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
39.1%
9/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Feeling abnormal
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.1%
2/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Gait disturbance
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Influenza like illness
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Oedema
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.5%
3/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Oedema peripheral
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
26.9%
7/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.8%
3/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Peripheral swelling
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
General disorders
Pyrexia
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
16.0%
4/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.5%
3/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.1%
2/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.1%
2/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.8%
3/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.9%
2/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Influenza
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.2%
4/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
4/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.2%
5/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.9%
2/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
15.2%
5/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Oral herpes
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.2%
4/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Pharyngitis
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Puncture site infection
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Sinusitis
|
10.7%
3/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Tooth infection
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.0%
3/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.1%
4/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Blood pressure increased
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Blood sodium decreased
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.9%
2/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
16.0%
4/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.2%
5/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.8%
3/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.1%
4/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.9%
2/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.5%
3/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
15.4%
4/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.1%
4/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.6%
5/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.2%
4/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.9%
2/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
17.9%
5/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
5/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
15.4%
4/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.8%
3/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.1%
2/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.6%
5/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.2%
4/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.1%
4/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
14.3%
4/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.7%
3/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
13.5%
7/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
10.2%
5/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.8%
3/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
28.6%
8/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
25.0%
7/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
28.0%
7/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
23.1%
12/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
28.6%
14/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
17.6%
6/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
27.3%
9/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
30.4%
7/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
15.4%
4/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
66.7%
2/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
40.0%
2/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Lethargy
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.0%
3/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.5%
3/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Somnolence
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Nervous system disorders
Tremor
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.2%
4/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Agitation
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Depression
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
14.3%
4/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
16.0%
4/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
15.4%
4/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
15.4%
8/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.4%
10/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.8%
4/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
17.4%
4/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Irritability
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
5.9%
2/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Psychiatric disorders
Sleep disorder
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
4/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Reproductive system and breast disorders
Gynaecomastia
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
14.3%
4/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
16.0%
4/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
15.4%
4/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.6%
5/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
16.3%
8/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.8%
4/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
21.2%
7/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
13.6%
3/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
17.4%
4/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.0%
3/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.5%
3/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
17.3%
9/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.2%
4/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
14.7%
5/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.6%
5/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
1/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
2/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.5%
1/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
2/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
1.9%
1/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.2%
6/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
3/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
5/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
28.6%
8/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.0%
3/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
15.4%
4/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.6%
5/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
12.2%
6/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.8%
4/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
21.2%
7/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.7%
2/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
33.3%
1/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
14.3%
4/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
8.0%
2/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
2/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
7.7%
4/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
11.8%
4/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.0%
1/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.6%
1/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Flushing
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Haematoma
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
6.1%
3/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Hot flush
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.0%
1/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
20.0%
1/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/28 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/25 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/26 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
3.8%
2/52 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.0%
1/49 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
2.9%
1/34 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/33 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
9.1%
2/22 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
4.3%
1/23 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/5 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
0.00%
0/3 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
50.0%
1/2 • Up to 24 weeks on treatment plus 30 days
Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
|
Additional Information
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