Trial Outcomes & Findings for Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection (NCT NCT02175758)
NCT ID: NCT02175758
Last Updated: 2019-04-30
Results Overview
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7
Results posted on
2019-04-30
Participant Flow
Participants were enrolled at study sites in Australia, Europe, Russia, New Zealand, and the United States. The first participant was screened on 07 July 2014. The last study visit occurred on 13 September 2018.
135 participants were screened.
Participant milestones
| Measure |
12 to < 18 Years Old - SOF+RBV 12 Weeks
Participants 12 to \< 18 years of age with hepatitis C virus (HCV) genotype 2 received sofosbuvir (SOF) 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + ribavirin (RBV) capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the Pharmacokinetic (PK) Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
12 to < 18 Years Old - SOF+RBV 24 Weeks
Participants 12 to \< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
6 to < 12 Years Old - SOF+RBV 12 Weeks
Participants 6 to \< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
|---|---|---|---|---|---|---|
|
PK Lead-in Phase
STARTED
|
4
|
6
|
2
|
10
|
4
|
8
|
|
PK Lead-in Phase
COMPLETED
|
4
|
6
|
2
|
10
|
4
|
8
|
|
PK Lead-in Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Phase
STARTED
|
13
|
39
|
13
|
28
|
5
|
8
|
|
Treatment Phase
COMPLETED
|
13
|
38
|
13
|
28
|
4
|
8
|
|
Treatment Phase
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
12 to < 18 Years Old - SOF+RBV 12 Weeks
Participants 12 to \< 18 years of age with hepatitis C virus (HCV) genotype 2 received sofosbuvir (SOF) 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + ribavirin (RBV) capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the Pharmacokinetic (PK) Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
12 to < 18 Years Old - SOF+RBV 24 Weeks
Participants 12 to \< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
6 to < 12 Years Old - SOF+RBV 12 Weeks
Participants 6 to \< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
|---|---|---|---|---|---|---|
|
Treatment Phase
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Phase
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
12 to < 18 Years Old - SOF+RBV 12 Weeks
n=13 Participants
Participants 12 to \< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
12 to < 18 Years Old - SOF+RBV 24 Weeks
n=39 Participants
Participants 12 to \< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 12 Weeks
n=13 Participants
Participants 6 to \< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
15 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
15 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
8 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
9 years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
4 years
STANDARD_DEVIATION 0.8 • n=21 Participants
|
5 years
STANDARD_DEVIATION 0.8 • n=10 Participants
|
11 years
STANDARD_DEVIATION 4.2 • n=115 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
61 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
95 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
11 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
85 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 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
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
New Zealand
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
46 Participants
n=115 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Region of Enrollment
Russia
|
2 Participants
n=5 Participants
|
15 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
|
|
HCV RNA Category
< 800,000 IU/mL
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
50 Participants
n=115 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
8 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7Population: Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=10 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=10 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=10 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF)
|
9106.0 h*ng/mL
Standard Deviation 2601.96
|
7651.2 h*ng/mL
Standard Deviation 1723.32
|
10293.7 h*ng/mL
Standard Deviation 1860.57
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set included all participants who took at least 1 dose of study drug.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=52 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=54 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=13 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
|
98.1 percentage of participants
Interval 89.7 to 100.0
|
98.1 percentage of participants
Interval 90.1 to 100.0
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)Population: Participants who were enrolled in the PK lead-in phase with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=4 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=6 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=2 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=10 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=4 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 2
|
-4.84 log10 IU/mL
Standard Deviation 0.743
|
-4.34 log10 IU/mL
Standard Deviation 0.758
|
-4.92 log10 IU/mL
Standard Deviation 0.674
|
-4.56 log10 IU/mL
Standard Deviation 1.553
|
-4.31 log10 IU/mL
Standard Deviation 0.846
|
-3.94 log10 IU/mL
Standard Deviation 0.422
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 4
|
-4.84 log10 IU/mL
Standard Deviation 0.743
|
-4.34 log10 IU/mL
Standard Deviation 0.758
|
-4.92 log10 IU/mL
Standard Deviation 0.674
|
-4.60 log10 IU/mL
Standard Deviation 1.686
|
-4.42 log10 IU/mL
Standard Deviation 1.006
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 8
|
-4.84 log10 IU/mL
Standard Deviation 0.743
|
-4.34 log10 IU/mL
Standard Deviation 0.758
|
-4.92 log10 IU/mL
Standard Deviation 0.674
|
-4.61 log10 IU/mL
Standard Deviation 1.700
|
-4.52 log10 IU/mL
Standard Deviation 1.177
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 12
|
-4.84 log10 IU/mL
Standard Deviation 0.743
|
-4.34 log10 IU/mL
Standard Deviation 0.758
|
-4.92 log10 IU/mL
Standard Deviation 0.674
|
-4.61 log10 IU/mL
Standard Deviation 1.700
|
-4.52 log10 IU/mL
Standard Deviation 1.177
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 16
|
—
|
-4.34 log10 IU/mL
Standard Deviation 0.758
|
—
|
-4.61 log10 IU/mL
Standard Deviation 1.700
|
—
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 20
|
—
|
-4.34 log10 IU/mL
Standard Deviation 0.758
|
—
|
-4.61 log10 IU/mL
Standard Deviation 1.700
|
—
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 24
|
—
|
-4.34 log10 IU/mL
Standard Deviation 0.758
|
—
|
-4.61 log10 IU/mL
Standard Deviation 1.700
|
—
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 1
|
-3.98 log10 IU/mL
Standard Deviation 1.056
|
-4.23 log10 IU/mL
Standard Deviation 0.765
|
-3.82 log10 IU/mL
Standard Deviation 0.447
|
-3.78 log10 IU/mL
Standard Deviation 1.234
|
-4.12 log10 IU/mL
Standard Deviation 0.632
|
-3.53 log10 IU/mL
Standard Deviation 0.347
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 7Population: Participants who were enrolled in the PK lead-in phase were analyzed.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=10 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=12 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=12 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Participants in the Full Analysis Set were analyzed.
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Participants in the Full Analysis Set were analyzed.
Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
|
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 were analyzed.
Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
|
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: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)Population: Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 1
|
-4.25 log10 IU/mL
Standard Deviation 0.986
|
-4.12 log10 IU/mL
Standard Deviation 0.733
|
-4.12 log10 IU/mL
Standard Deviation 0.692
|
-3.88 log10 IU/mL
Standard Deviation 0.928
|
-4.12 log10 IU/mL
Standard Deviation 0.632
|
-3.53 log10 IU/mL
Standard Deviation 0.347
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 2
|
-4.74 log10 IU/mL
Standard Deviation 0.980
|
-4.86 log10 IU/mL
Standard Deviation 0.702
|
-4.55 log10 IU/mL
Standard Deviation 0.812
|
-4.51 log10 IU/mL
Standard Deviation 1.102
|
-4.31 log10 IU/mL
Standard Deviation 0.846
|
-3.94 log10 IU/mL
Standard Deviation 0.422
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 4
|
-4.74 log10 IU/mL
Standard Deviation 0.980
|
-5.01 log10 IU/mL
Standard Deviation 0.760
|
-4.68 log10 IU/mL
Standard Deviation 0.843
|
-4.56 log10 IU/mL
Standard Deviation 1.171
|
-4.42 log10 IU/mL
Standard Deviation 1.006
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 8
|
-4.74 log10 IU/mL
Standard Deviation 0.980
|
-5.02 log10 IU/mL
Standard Deviation 0.771
|
-4.68 log10 IU/mL
Standard Deviation 0.843
|
-4.54 log10 IU/mL
Standard Deviation 1.191
|
-4.52 log10 IU/mL
Standard Deviation 1.177
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 12
|
-4.74 log10 IU/mL
Standard Deviation 0.980
|
-5.02 log10 IU/mL
Standard Deviation 0.771
|
-4.68 log10 IU/mL
Standard Deviation 0.843
|
-4.57 log10 IU/mL
Standard Deviation 1.178
|
-4.52 log10 IU/mL
Standard Deviation 1.177
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 16
|
—
|
-5.02 log10 IU/mL
Standard Deviation 0.771
|
—
|
-4.57 log10 IU/mL
Standard Deviation 1.178
|
—
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 20
|
—
|
-5.02 log10 IU/mL
Standard Deviation 0.771
|
—
|
-4.57 log10 IU/mL
Standard Deviation 1.178
|
—
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 24
|
—
|
-5.02 log10 IU/mL
Standard Deviation 0.771
|
—
|
-4.57 log10 IU/mL
Standard Deviation 1.178
|
—
|
-3.97 log10 IU/mL
Standard Deviation 0.453
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)Population: Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 20
|
—
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
—
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
—
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 1
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
30.8 percentage of participants
Interval 17.0 to 47.6
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 2
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
74.4 percentage of participants
Interval 57.9 to 87.0
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
78.6 percentage of participants
Interval 59.0 to 91.7
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 4
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
92.3 percentage of participants
Interval 79.1 to 98.4
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 8
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 12
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 16
|
—
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
—
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
—
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 24
|
—
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
—
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
—
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4Population: Participants in the Full Analysis Set with ALT \> ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks. One participant in the 3 to \< 6 Years Old 12 Weeks group had ALT \> ULN at Baseline, but had no other available data.
ALT normalization was defined as ALT \> the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. One participant in the 3 to \< 6 Years Old 12 Weeks group had ALT \> ULN at Baseline, but had no other available data.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=4 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=22 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=4 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=16 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=2 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 1
|
50.0 percentage of participants
|
63.6 percentage of participants
|
25.0 percentage of participants
|
75.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 2
|
100.0 percentage of participants
|
90.9 percentage of participants
|
100.0 percentage of participants
|
93.3 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 4
|
100.0 percentage of participants
|
95.5 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 8
|
100.0 percentage of participants
|
95.5 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 12
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 16
|
—
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 20
|
—
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 24
|
—
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Posttreatment Week 4
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24Population: Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 1
|
0.1 centimeters
Standard Deviation 1.10
|
0.0 centimeters
Standard Deviation 0.57
|
0.0 centimeters
Standard Deviation 0.57
|
0.0 centimeters
Standard Deviation 0.73
|
0.3 centimeters
Standard Deviation 1.12
|
0.3 centimeters
Standard Deviation 0.75
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 2
|
0.1 centimeters
Standard Deviation 1.07
|
-0.1 centimeters
Standard Deviation 0.59
|
0.1 centimeters
Standard Deviation 0.66
|
0.0 centimeters
Standard Deviation 0.54
|
0.7 centimeters
Standard Deviation 1.09
|
0.3 centimeters
Standard Deviation 0.50
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 4
|
0.2 centimeters
Standard Deviation 1.20
|
0.2 centimeters
Standard Deviation 0.78
|
0.3 centimeters
Standard Deviation 0.67
|
0.4 centimeters
Standard Deviation 0.74
|
0.9 centimeters
Standard Deviation 0.87
|
0.5 centimeters
Standard Deviation 0.67
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 8
|
0.3 centimeters
Standard Deviation 1.27
|
0.2 centimeters
Standard Deviation 0.85
|
1.0 centimeters
Standard Deviation 1.00
|
0.4 centimeters
Standard Deviation 0.62
|
0.9 centimeters
Standard Deviation 0.72
|
0.8 centimeters
Standard Deviation 0.51
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 12
|
0.5 centimeters
Standard Deviation 1.68
|
0.3 centimeters
Standard Deviation 0.95
|
0.8 centimeters
Standard Deviation 0.81
|
0.7 centimeters
Standard Deviation 0.68
|
1.5 centimeters
Standard Deviation 0.45
|
1.7 centimeters
Standard Deviation 1.84
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 16
|
—
|
0.4 centimeters
Standard Deviation 0.91
|
—
|
1.1 centimeters
Standard Deviation 0.93
|
—
|
1.8 centimeters
Standard Deviation 0.79
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 20
|
—
|
0.5 centimeters
Standard Deviation 1.10
|
—
|
1.6 centimeters
Standard Deviation 1.15
|
—
|
2.5 centimeters
Standard Deviation 1.01
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 24
|
—
|
0.8 centimeters
Standard Deviation 1.54
|
—
|
2.1 centimeters
Standard Deviation 0.88
|
—
|
2.7 centimeters
Standard Deviation 1.05
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Posttreatment Week 4
|
0.5 centimeters
Standard Deviation 1.79
|
0.9 centimeters
Standard Deviation 1.70
|
1.4 centimeters
Standard Deviation 0.80
|
2.6 centimeters
Standard Deviation 1.17
|
1.6 centimeters
Standard Deviation 0.91
|
3.5 centimeters
Standard Deviation 0.85
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Posttreatment Week 12
|
1.4 centimeters
Standard Deviation 1.65
|
1.3 centimeters
Standard Deviation 1.90
|
2.4 centimeters
Standard Deviation 1.02
|
3.8 centimeters
Standard Deviation 1.30
|
2.8 centimeters
Standard Deviation 1.81
|
4.0 centimeters
Standard Deviation 0.95
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Posttreatment Week 24
|
1.6 centimeters
Standard Deviation 1.89
|
1.8 centimeters
Standard Deviation 2.83
|
4.2 centimeters
Standard Deviation 1.11
|
5.1 centimeters
Standard Deviation 1.59
|
5.0 centimeters
Standard Deviation 1.61
|
5.7 centimeters
Standard Deviation 1.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24Population: Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=39 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 Participants
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 1
|
-0.7 kilograms
Standard Deviation 1.28
|
-0.4 kilograms
Standard Deviation 1.36
|
0.2 kilograms
Standard Deviation 0.82
|
0.0 kilograms
Standard Deviation 0.55
|
0.2 kilograms
Standard Deviation 0.10
|
-0.2 kilograms
Standard Deviation 0.51
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 2
|
-0.2 kilograms
Standard Deviation 0.87
|
-0.3 kilograms
Standard Deviation 0.99
|
0.3 kilograms
Standard Deviation 1.08
|
0.0 kilograms
Standard Deviation 0.64
|
0.5 kilograms
Standard Deviation 0.21
|
-0.1 kilograms
Standard Deviation 0.50
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 4
|
-0.2 kilograms
Standard Deviation 1.67
|
-0.1 kilograms
Standard Deviation 1.15
|
0.4 kilograms
Standard Deviation 0.90
|
0.1 kilograms
Standard Deviation 0.90
|
0.0 kilograms
Standard Deviation 0.22
|
-0.1 kilograms
Standard Deviation 0.49
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 8
|
-0.5 kilograms
Standard Deviation 2.39
|
0.0 kilograms
Standard Deviation 1.53
|
0.6 kilograms
Standard Deviation 1.57
|
0.1 kilograms
Standard Deviation 1.21
|
0.3 kilograms
Standard Deviation 0.14
|
0.0 kilograms
Standard Deviation 0.55
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 12
|
-0.4 kilograms
Standard Deviation 2.62
|
-0.1 kilograms
Standard Deviation 2.01
|
0.9 kilograms
Standard Deviation 2.15
|
0.5 kilograms
Standard Deviation 1.35
|
0.3 kilograms
Standard Deviation 0.22
|
0.1 kilograms
Standard Deviation 0.85
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 16
|
—
|
0.2 kilograms
Standard Deviation 2.35
|
—
|
0.6 kilograms
Standard Deviation 1.34
|
—
|
0.1 kilograms
Standard Deviation 0.76
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 20
|
—
|
0.1 kilograms
Standard Deviation 2.65
|
—
|
0.9 kilograms
Standard Deviation 1.59
|
—
|
0.4 kilograms
Standard Deviation 0.86
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 24
|
—
|
0.5 kilograms
Standard Deviation 3.13
|
—
|
1.2 kilograms
Standard Deviation 1.91
|
—
|
0.4 kilograms
Standard Deviation 1.03
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Posttreatment Week 4
|
-0.3 kilograms
Standard Deviation 3.19
|
0.9 kilograms
Standard Deviation 3.24
|
1.2 kilograms
Standard Deviation 2.20
|
1.3 kilograms
Standard Deviation 2.19
|
0.5 kilograms
Standard Deviation 0.27
|
0.7 kilograms
Standard Deviation 1.05
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Posttreatment Week 12
|
0.9 kilograms
Standard Deviation 2.69
|
2.1 kilograms
Standard Deviation 3.73
|
2.1 kilograms
Standard Deviation 3.28
|
2.2 kilograms
Standard Deviation 2.21
|
1.0 kilograms
Standard Deviation 0.88
|
0.9 kilograms
Standard Deviation 1.12
|
—
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Posttreatment Week 24
|
2.5 kilograms
Standard Deviation 4.98
|
3.0 kilograms
Standard Deviation 4.62
|
3.8 kilograms
Standard Deviation 3.67
|
3.5 kilograms
Standard Deviation 2.42
|
1.3 kilograms
Standard Deviation 1.10
|
1.7 kilograms
Standard Deviation 1.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24Population: Male participants in the Safety Analysis Set with available data were analyzed.
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=31 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=11 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=3 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · No Change
|
23 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · Increase
|
8 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · No Change
|
20 Participants
|
9 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · Increase
|
10 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · No Change
|
20 Participants
|
9 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · Increase
|
11 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24Population: Male participants in the Safety Analysis Set with available data were analyzed.
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=31 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=11 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=3 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
End of Treatment · No Change
|
24 Participants
|
11 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
End of Treatment · Increase
|
7 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
End of Treatment · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 12 · No Change
|
21 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 12 · Increase
|
9 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 12 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 24 · No Change
|
20 Participants
|
9 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 24 · Increase
|
11 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 24 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24Population: Female participants in the Safety Analysis Set with available data were analyzed.
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=21 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=30 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · No Change
|
20 Participants
|
24 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · Increase
|
1 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · No Change
|
18 Participants
|
23 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · Increase
|
2 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · No Change
|
18 Participants
|
22 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · Increase
|
2 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24Population: Female participants in the Safety Analysis Set with available data were analyzed.
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=21 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=30 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=8 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
End of Treatment · No Change
|
20 Participants
|
24 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
End of Treatment · Increase
|
1 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
End of Treatment · Decrease
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 12 · No Change
|
17 Participants
|
24 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 12 · Increase
|
3 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 12 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 24 · No Change
|
16 Participants
|
19 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 24 · Increase
|
4 Participants
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 24 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants in the Safety Analysis Set who performed the palatability assessment were analyzed.
Participants were asked if they were able to taste the SOF oral granules.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks
n=1 Participants
Participants 12 to \< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks
n=7 Participants
Participants 6 to \< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks
n=12 Participants
Participants 3 to \< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules
Able to Taste SOF Granules: Yes
|
0 percentage of participants
|
42.9 percentage of participants
|
75.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules
Able to Taste SOF Granules: No
|
100.0 percentage of participants
|
57.1 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
12 to < 18 Years Old - SOF+RBV 12 Weeks
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
12 to < 18 Years Old - SOF+RBV 24 Weeks
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
6 to < 12 Years Old - SOF+RBV 12 Weeks
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
6 to < 12 Years Old - SOF+RBV 24 Weeks
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
3 to < 6 Years Old - SOF+RBV 12 Weeks
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
3 to < 6 Years Old - SOF+RBV 24 Weeks
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
12 to < 18 Years Old - SOF+RBV 12 Weeks
n=13 participants at risk
Participants 12 to \< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
12 to < 18 Years Old - SOF+RBV 24 Weeks
n=39 participants at risk
Participants 12 to \< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 12 Weeks
n=13 participants at risk
Participants 6 to \< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 participants at risk
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 participants at risk
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 participants at risk
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
12 to < 18 Years Old - SOF+RBV 12 Weeks
n=13 participants at risk
Participants 12 to \< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
12 to < 18 Years Old - SOF+RBV 24 Weeks
n=39 participants at risk
Participants 12 to \< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
6 to < 12 Years Old - SOF+RBV 12 Weeks
n=13 participants at risk
Participants 6 to \< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
6 to < 12 Years Old - SOF+RBV 24 Weeks
n=28 participants at risk
Participants 6 to \< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - SOF+RBV 12 Weeks
n=5 participants at risk
Participants 3 to \< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.
|
3 to < 6 Years Old - SOF+RBV 24 Weeks
n=8 participants at risk
Participants 3 to \< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Scratch
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Product use issue
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Cardiac murmur
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
15.4%
2/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
37.5%
3/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.7%
3/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.7%
3/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.4%
2/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
2/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.7%
3/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
40.0%
2/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
37.5%
3/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
28.2%
11/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
14.3%
4/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral contusion
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
15.4%
2/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
39.3%
11/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
60.0%
3/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
37.5%
3/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.8%
5/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.3%
4/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
23.1%
3/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
17.9%
5/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
14.3%
4/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.7%
3/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Impetigo
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
14.3%
4/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.3%
4/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
23.1%
3/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
23.1%
9/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
30.8%
4/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
28.6%
8/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Product Issues
Product taste abnormal
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Irritability
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
25.0%
7/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.3%
4/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
14.3%
4/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.7%
3/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
1/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
2.6%
1/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
3.6%
1/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.7%
3/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
7.1%
2/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
5.1%
2/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
7.7%
1/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/39 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/13 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/28 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/5 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER