Trial Outcomes & Findings for Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection (NCT NCT01826981)
NCT ID: NCT01826981
Last Updated: 2018-11-16
Results Overview
SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
359 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at a total of 2 study sites in New Zealand. The first participant was screened on 3 April 2016. The last study visit occurred on 25 May 2015.
446 participants were screened.
Participant milestones
| Measure |
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and Child Pugh-Turcotte (CPT) B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
Sofosbuvir (SOF) 400 mg once daily+Velpatasvir (VEL) 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
10
|
25
|
26
|
25
|
26
|
25
|
51
|
20
|
27
|
24
|
27
|
26
|
20
|
8
|
|
Overall Study
COMPLETED
|
19
|
9
|
25
|
26
|
18
|
25
|
24
|
40
|
13
|
26
|
22
|
25
|
25
|
15
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
7
|
1
|
1
|
11
|
7
|
1
|
2
|
2
|
1
|
5
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and Child Pugh-Turcotte (CPT) B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
Sofosbuvir (SOF) 400 mg once daily+Velpatasvir (VEL) 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
5
|
0
|
0
|
8
|
7
|
0
|
1
|
0
|
0
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Upper G-I Haemorrhage
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Enrolled/Randomized but Not Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
Baseline characteristics by cohort
| Measure |
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=24 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Total
n=358 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55 Years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
49 Years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
56 Years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
55 Years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
43 Years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
48 Years
STANDARD_DEVIATION 9.2 • n=10 Participants
|
51 Years
STANDARD_DEVIATION 13.9 • n=115 Participants
|
52 Years
STANDARD_DEVIATION 8.2 • n=24 Participants
|
56 Years
STANDARD_DEVIATION 5.5 • n=42 Participants
|
48 Years
STANDARD_DEVIATION 7.9 • n=42 Participants
|
47 Years
STANDARD_DEVIATION 7.9 • n=42 Participants
|
50 Years
STANDARD_DEVIATION 10.2 • n=42 Participants
|
47 Years
STANDARD_DEVIATION 10.3 • n=36 Participants
|
54 Years
STANDARD_DEVIATION 7.0 • n=36 Participants
|
53 Years
STANDARD_DEVIATION 6.9 • n=24 Participants
|
50.7 Years
STANDARD_DEVIATION 9.44 • n=135 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
124 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
39 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
234 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
White
|
18 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
24 participants
n=4 Participants
|
22 participants
n=21 Participants
|
23 participants
n=10 Participants
|
3 participants
n=115 Participants
|
40 participants
n=24 Participants
|
17 participants
n=42 Participants
|
20 participants
n=42 Participants
|
20 participants
n=42 Participants
|
20 participants
n=42 Participants
|
19 participants
n=36 Participants
|
18 participants
n=36 Participants
|
3 participants
n=24 Participants
|
278 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 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
|
22 participants
n=115 Participants
|
3 participants
n=24 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
1 participants
n=24 Participants
|
32 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
5 participants
n=24 Participants
|
2 participants
n=42 Participants
|
5 participants
n=42 Participants
|
2 participants
n=42 Participants
|
3 participants
n=42 Participants
|
6 participants
n=36 Participants
|
1 participants
n=36 Participants
|
4 participants
n=24 Participants
|
34 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
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=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
1 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
2 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
2 participants
n=42 Participants
|
3 participants
n=42 Participants
|
0 participants
n=36 Participants
|
1 participants
n=36 Participants
|
0 participants
n=24 Participants
|
13 participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
19 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
26 participants
n=4 Participants
|
25 participants
n=21 Participants
|
26 participants
n=10 Participants
|
25 participants
n=115 Participants
|
50 participants
n=24 Participants
|
20 participants
n=42 Participants
|
27 participants
n=42 Participants
|
24 participants
n=42 Participants
|
27 participants
n=42 Participants
|
26 participants
n=36 Participants
|
20 participants
n=36 Participants
|
8 participants
n=24 Participants
|
358 participants
n=135 Participants
|
|
HCV Genotype
1b with possible mixed infection with Genotype 4
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 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=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
1 participants
n=135 Participants
|
|
HCV Genotype
Genotype 1a
|
16 participants
n=5 Participants
|
0 participants
n=7 Participants
|
15 participants
n=5 Participants
|
22 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
18 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
9 participants
n=36 Participants
|
6 participants
n=24 Participants
|
86 participants
n=135 Participants
|
|
HCV Genotype
Genotype 1a with possible 6 (subtypes c - l)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
1 participants
n=135 Participants
|
|
HCV Genotype
Genotype 1b
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
2 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
2 participants
n=24 Participants
|
19 participants
n=135 Participants
|
|
HCV Genotype
Genotype 3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
3 participants
n=24 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
7 participants
n=135 Participants
|
|
HCV Genotype
Genotype 3a
|
0 participants
n=5 Participants
|
10 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
24 participants
n=21 Participants
|
25 participants
n=10 Participants
|
0 participants
n=115 Participants
|
46 participants
n=24 Participants
|
0 participants
n=42 Participants
|
25 participants
n=42 Participants
|
22 participants
n=42 Participants
|
27 participants
n=42 Participants
|
26 participants
n=36 Participants
|
10 participants
n=36 Participants
|
0 participants
n=24 Participants
|
215 participants
n=135 Participants
|
|
HCV Genotype
Genotype 3k
|
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=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
1 participants
n=135 Participants
|
|
HCV Genotype
Genotype 6 (subtypes c - l)
|
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
|
17 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
17 participants
n=135 Participants
|
|
HCV Genotype
Genotype 6a or 6b
|
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
|
8 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
8 participants
n=135 Participants
|
|
HCV Genotype
Indeterminate genotype. Sequencing indicates GT3a
|
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
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
1 participants
n=135 Participants
|
|
HCV Genotype
Indeterminate pattern. Sequencing indicates GT3k
|
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
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
1 participants
n=135 Participants
|
|
HCV Genotype
Missing
|
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=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
1 participants
n=36 Participants
|
0 participants
n=24 Participants
|
1 participants
n=135 Participants
|
|
Cirrhosis Status
No
|
18 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
9 participants
n=4 Participants
|
21 participants
n=21 Participants
|
20 participants
n=10 Participants
|
23 participants
n=115 Participants
|
28 participants
n=24 Participants
|
0 participants
n=42 Participants
|
27 participants
n=42 Participants
|
24 participants
n=42 Participants
|
27 participants
n=42 Participants
|
26 participants
n=36 Participants
|
6 participants
n=36 Participants
|
6 participants
n=24 Participants
|
251 participants
n=135 Participants
|
|
Cirrhosis Status
Yes
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
18 participants
n=5 Participants
|
17 participants
n=4 Participants
|
4 participants
n=21 Participants
|
6 participants
n=10 Participants
|
2 participants
n=115 Participants
|
22 participants
n=24 Participants
|
20 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
14 participants
n=36 Participants
|
2 participants
n=24 Participants
|
107 participants
n=135 Participants
|
|
IL28b Status
CC
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
15 participants
n=10 Participants
|
20 participants
n=115 Participants
|
18 participants
n=24 Participants
|
7 participants
n=42 Participants
|
10 participants
n=42 Participants
|
6 participants
n=42 Participants
|
15 participants
n=42 Participants
|
14 participants
n=36 Participants
|
7 participants
n=36 Participants
|
7 participants
n=24 Participants
|
145 participants
n=135 Participants
|
|
IL28b Status
CT
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
19 participants
n=4 Participants
|
10 participants
n=21 Participants
|
6 participants
n=10 Participants
|
5 participants
n=115 Participants
|
27 participants
n=24 Participants
|
6 participants
n=42 Participants
|
13 participants
n=42 Participants
|
15 participants
n=42 Participants
|
11 participants
n=42 Participants
|
10 participants
n=36 Participants
|
7 participants
n=36 Participants
|
1 participants
n=24 Participants
|
159 participants
n=135 Participants
|
|
IL28b Status
TT
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
5 participants
n=10 Participants
|
0 participants
n=115 Participants
|
5 participants
n=24 Participants
|
7 participants
n=42 Participants
|
4 participants
n=42 Participants
|
3 participants
n=42 Participants
|
1 participants
n=42 Participants
|
2 participants
n=36 Participants
|
6 participants
n=36 Participants
|
0 participants
n=24 Participants
|
54 participants
n=135 Participants
|
|
HCV RNA
|
6.3 log 10 IU/mL
STANDARD_DEVIATION 0.51 • n=5 Participants
|
6.5 log 10 IU/mL
STANDARD_DEVIATION 0.63 • n=7 Participants
|
6.5 log 10 IU/mL
STANDARD_DEVIATION 0.39 • n=5 Participants
|
6.1 log 10 IU/mL
STANDARD_DEVIATION 0.69 • n=4 Participants
|
6.3 log 10 IU/mL
STANDARD_DEVIATION 0.88 • n=21 Participants
|
6.3 log 10 IU/mL
STANDARD_DEVIATION 0.87 • n=10 Participants
|
6.7 log 10 IU/mL
STANDARD_DEVIATION 0.67 • n=115 Participants
|
6.3 log 10 IU/mL
STANDARD_DEVIATION 0.76 • n=24 Participants
|
6.0 log 10 IU/mL
STANDARD_DEVIATION 0.48 • n=42 Participants
|
5.9 log 10 IU/mL
STANDARD_DEVIATION 0.86 • n=42 Participants
|
6.3 log 10 IU/mL
STANDARD_DEVIATION 0.69 • n=42 Participants
|
6.0 log 10 IU/mL
STANDARD_DEVIATION 0.71 • n=42 Participants
|
6.2 log 10 IU/mL
STANDARD_DEVIATION 0.92 • n=36 Participants
|
6.0 log 10 IU/mL
STANDARD_DEVIATION 0.48 • n=36 Participants
|
6.0 log 10 IU/mL
STANDARD_DEVIATION 10.9 • n=24 Participants
|
6.2 log 10 IU/mL
STANDARD_DEVIATION 0.76 • n=135 Participants
|
|
HCV RNA Category
< 800,000
|
3 IU/mL
n=5 Participants
|
1 IU/mL
n=7 Participants
|
2 IU/mL
n=5 Participants
|
9 IU/mL
n=4 Participants
|
9 IU/mL
n=21 Participants
|
6 IU/mL
n=10 Participants
|
2 IU/mL
n=115 Participants
|
15 IU/mL
n=24 Participants
|
5 IU/mL
n=42 Participants
|
14 IU/mL
n=42 Participants
|
10 IU/mL
n=42 Participants
|
11 IU/mL
n=42 Participants
|
7 IU/mL
n=36 Participants
|
6 IU/mL
n=36 Participants
|
2 IU/mL
n=24 Participants
|
102 IU/mL
n=135 Participants
|
|
HCV RNA Category
>= 800,000
|
16 IU/mL
n=5 Participants
|
9 IU/mL
n=7 Participants
|
23 IU/mL
n=5 Participants
|
17 IU/mL
n=4 Participants
|
16 IU/mL
n=21 Participants
|
20 IU/mL
n=10 Participants
|
23 IU/mL
n=115 Participants
|
35 IU/mL
n=24 Participants
|
15 IU/mL
n=42 Participants
|
13 IU/mL
n=42 Participants
|
14 IU/mL
n=42 Participants
|
16 IU/mL
n=42 Participants
|
19 IU/mL
n=36 Participants
|
14 IU/mL
n=36 Participants
|
6 IU/mL
n=24 Participants
|
256 IU/mL
n=135 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full analysis set: Participants who were randomized and received at least 1 dose of study drug.
SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=24 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
75 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
90 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
64.0 percentage of participants
|
100 percentage of participants
|
96.0 percentage of participants
|
82.0 percentage of participants
|
65.0 percentage of participants
|
100 percentage of participants
|
87.5 percentage of participants
|
96.3 percentage of participants
|
100.0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks plus 30 daysPopulation: Safety Analysis Set
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=24 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
|
5.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.0 Percentage of participants
|
0 Percentage of participants
|
4.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.2 Percentage of participants
|
0 Percentage of participants
|
3.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=24 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 1
|
15.0 percentage of participants
|
12.5 percentage of participants
|
15.8 percentage of participants
|
30.0 percentage of participants
|
4.0 percentage of participants
|
11.5 percentage of participants
|
20.0 percentage of participants
|
11.5 percentage of participants
|
12.0 percentage of participants
|
12.0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
4.2 percentage of participants
|
26.9 percentage of participants
|
19.2 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 2
|
45.0 percentage of participants
|
75.0 percentage of participants
|
63.2 percentage of participants
|
50.0 percentage of participants
|
44.0 percentage of participants
|
53.8 percentage of participants
|
64.0 percentage of participants
|
61.5 percentage of participants
|
56.0 percentage of participants
|
52.0 percentage of participants
|
25.0 percentage of participants
|
70.4 percentage of participants
|
66.7 percentage of participants
|
65.4 percentage of participants
|
69.2 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 6, and 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=24 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=23 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 4
|
75.0 percentage of participants
|
87.5 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
84.0 percentage of participants
|
92.3 percentage of participants
|
95.8 percentage of participants
|
88.5 percentage of participants
|
96.0 percentage of participants
|
96.0 percentage of participants
|
75.0 percentage of participants
|
96.3 percentage of participants
|
95.7 percentage of participants
|
92.3 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 6
|
90.0 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
|
96.0 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
|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 8
|
90.0 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
|
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 10Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=23 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=24 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=20 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=8 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
|
—
|
—
|
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
|
98.0 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 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=23 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=24 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=24 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=20 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=8 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
|
—
|
—
|
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
|
98.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 16, 20, and 24Population: Full Analysis Set
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=20 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 16
|
—
|
—
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 20
|
—
|
—
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Week 24
|
—
|
—
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 2, 4, 8, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=24 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=23 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
SVR2
|
95.0 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
|
72.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
90.0 percentage of participants
|
95.0 percentage of participants
|
100.0 percentage of participants
|
87.5 percentage of participants
|
96.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
SVR4
|
75.0 percentage of participants
|
87.5 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
84.0 percentage of participants
|
92.3 percentage of participants
|
95.8 percentage of participants
|
88.5 percentage of participants
|
96.0 percentage of participants
|
96.0 percentage of participants
|
75.0 percentage of participants
|
96.3 percentage of participants
|
95.7 percentage of participants
|
92.3 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
SVR8
|
80.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
90.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
64.0 percentage of participants
|
100.0 percentage of participants
|
96.0 percentage of participants
|
82.0 percentage of participants
|
65.0 percentage of participants
|
100.0 percentage of participants
|
87.5 percentage of participants
|
96.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
SVR24
|
75.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
90.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
64.0 percentage of participants
|
100.0 percentage of participants
|
96.0 percentage of participants
|
82.0 percentage of participants
|
65.0 percentage of participants
|
100.0 percentage of participants
|
87.5 percentage of participants
|
96.3 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 16 and 20Population: Full Analysis Set included the participants who were randomized into Cohort 6 and received at least one dose of study drug.
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=8 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
SVR16
|
—
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
SVR20
|
—
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
On-treatment virologic failure was defined as: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=24 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With On-treatment Virologic Failure
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Outcome measures
| Measure |
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 Participants
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 Participants
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=24 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 Participants
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 Participants
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 Participants
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=23 Participants
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 Participants
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Viral Relapse
|
15.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
4.0 percentage of participants
|
16.3 percentage of participants
|
35.0 percentage of participants
|
0 percentage of participants
|
8.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 participants at risk
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 participants at risk
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 participants at risk
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 participants at risk
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=25 participants at risk
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 participants at risk
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 participants at risk
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 participants at risk
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 participants at risk
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 participants at risk
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 participants at risk
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 participants at risk
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=24 participants at risk
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=27 participants at risk
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 participants at risk
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Choroidal effusion
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Lens dislocation
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Seizure
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Agitation
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)
n=19 participants at risk
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
|
Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)
n=10 participants at risk
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)
n=25 participants at risk
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease
n=26 participants at risk
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
|
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
n=25 participants at risk
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
|
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
n=26 participants at risk
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
|
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
n=25 participants at risk
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
|
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
n=50 participants at risk
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
|
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)
n=20 participants at risk
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
|
Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
n=20 participants at risk
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
n=8 participants at risk
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
|
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)
n=27 participants at risk
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=24 participants at risk
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)
n=27 participants at risk
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
n=26 participants at risk
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
15.8%
3/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.4%
4/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.3%
2/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Eye irritation
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Eye pruritus
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Eyelid thickening
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
2/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dental caries
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.4%
4/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
16.0%
4/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
4/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.3%
2/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
14.8%
4/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
2/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
21.1%
4/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
30.0%
3/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
28.0%
7/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
42.3%
11/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
36.0%
9/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.4%
4/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
5/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.0%
3/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
14.8%
4/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
14.8%
4/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.5%
3/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.5%
3/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
16.7%
4/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Catheter site bruise
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Chest discomfort
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Chills
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
30.0%
3/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
31.6%
6/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
30.0%
3/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
5/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
34.6%
9/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
5/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
24.0%
6/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
26.0%
13/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
4/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
4/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
18.5%
5/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.5%
3/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
14.8%
4/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
26.9%
7/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Temperature intolerance
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Tenderness
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Ulcer
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Vessel puncture site phlebitis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Fungal skin infection
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Furuncle
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
2/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.5%
3/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
2/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
2/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
30.0%
6/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Oral herpes
|
10.5%
2/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Pertussis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Rhinitis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
21.1%
4/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
32.0%
8/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
19.2%
5/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
36.0%
9/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
34.6%
9/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
24.0%
6/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
18.0%
9/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
40.0%
8/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
30.0%
6/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.5%
3/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.1%
3/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.4%
4/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
16.0%
4/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
62.5%
5/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Chest crushing
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Investigations
Weight decreased
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
2/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.5%
3/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.3%
2/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
30.0%
3/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
2/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.5%
3/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
2/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.4%
4/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Amnesia
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
4/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
2/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
2/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
26.3%
5/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
2/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
40.0%
10/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
34.6%
9/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
40.0%
10/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
30.8%
8/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
26.0%
13/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
4/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.0%
3/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
22.2%
6/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.8%
5/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.1%
3/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.4%
4/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Lethargy
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
16.0%
4/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
6.0%
3/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.1%
3/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.5%
3/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Memory impairment
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Migraine
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Presyncope
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
2/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.3%
2/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Somnolence
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Syncope
|
10.5%
2/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Affect lability
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
36.8%
7/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
2/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
28.0%
7/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.5%
3/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
10/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.0%
3/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.5%
3/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
22.2%
6/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
4/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Panic attack
|
10.5%
2/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Tearfulness
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
2/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
2/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
5/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
4/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
4/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
2.0%
1/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
2/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
2/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
6.0%
3/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
6.0%
3/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
11.5%
3/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.1%
4/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
20.0%
2/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.7%
2/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
14.0%
7/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.0%
3/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
12.5%
3/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
15.4%
4/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.7%
1/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
5.0%
1/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/50 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/20 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
0.00%
0/27 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
3.8%
1/26 • Up to 24 Weeks plus 30 days
Safety Analysis Set
|
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